The Effect on Blood Cells, Known as Platelets, Using Pras... | NCT00385944

NCT00385944

ID	Type	Description	Link
H7T-MC-TABN	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Name	Class
Daiichi Sankyo	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prasugrel	Experimental	Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) prasugrel 10 mg and two placebo tablets, matched to clopidogrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of clopidogrel two 75 mg tablets and one placebo matched to prasugrel and 100 mg aspirin, all taken orally once a day for the next 14 days.	Drug: Prasugrel
Clopidogrel	Active Comparator	Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) Clopidogrel two 75 mg and one placebo tablet, matched to prasugrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of prasugrel one 10 mg tablet and two placebo tablets matched to clopidogrel and 100 mg aspirin, all taken orally once a day for the next 14 days.	Drug: Clopidogrel

Name	Type	Description	Arm Group Labels	Other Names
Prasugrel	Drug	Prasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period.	Prasugrel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)	Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).	14 days after maintenance dose (MD)

Secondary Outcomes

Measure	Description	Time Frame
MPA to 5 μM ADP	Maximum platelet aggregation to 5 μM ADP was assessed by LTA.	14 days after maintenance dose (MD)
Mean Residual Platelet Aggregation (RPA) to 20 µM ADP	Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Créteil		94010

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Prasugrel/Clopidogrel	One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

LY640315
Effient
Efient

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Prasugrel/Clopidogrel	One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
BG001	Clopidogrel/Prasugrel	One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00029 BG00127 BG00256

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063± 13.7 BG00158± 10.7 BG00261± 12.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG0016 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG00028 BG00125 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

France

Title	Measurements
	BG00029 BG00127 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)

Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).

The primary analysis was performed on the intent-to-treat (ITT) population, that is, all randomized subjects with a maintenance dose MPA measured for at least one of the treatments.

Posted

Mean

Standard Deviation

Percentage aggregation

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG00049 OG00147

Title

Denominators

Categories

Title	Measurements
	OG00027.1± 10.55 OG00140.3± 14.96

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		<0.001		Mean Difference (Net)	-12.91			2-Sided	95	-17.02	-8.81				No	Superiority or Other

Secondary

MPA to 5 μM ADP

Maximum platelet aggregation to 5 μM ADP was assessed by LTA.

Posted

Mean

Standard Deviation

Percentage aggregation

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

Mean Residual Platelet Aggregation (RPA) to 20 µM ADP

Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.

Posted

Mean

Standard Deviation

Percentage aggregation

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

Mean Residual Platelet Aggregation (RPA) to 5 µM ADP

Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.

Posted

Mean

Standard Deviation

Percentage aggregation

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

Inhibition Platelet Aggregation (IPA) to 20 μM ADP

IPA is calculated as a percent decrease of MPA from baseline using the following formula:

([MPA at baseline - MPA at time of postbaseline] / MPA at baseline) x 100%

Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)

Posted

Mean

Standard Deviation

Percentage inhibition

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

Inhibition Platelet Aggregation (IPA) to 5 μM ADP

IPA is calculated as a percent decrease of MPA from baseline using the following formula:

([MPA at baseline - MPA at time of postbaseline] / MPA at baseline) x 100%

Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)

Posted

Mean

Standard Deviation

Percentage inhibition

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP

IRPA is calculated as a percent decrease of RPA from baseline using the following formula:

([RPA at baseline - RPA at time of postbaseline] / RPA at baseline) x 100%

Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)

Posted

Mean

Standard Deviation

Percentage inhibition

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP

IRPA is calculated as a percent decrease of RPA from baseline using the following formula:

([RPA at baseline - RPA at time of postbaseline] / RPA at baseline) x 100%

Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)

Posted

Mean

Standard Deviation

Percentage inhibition

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

Platelet Reactivity Index (PRI)

Platelet Reactivity Index percentage was assessed by Vasodilator-stimulated phosphoprotein (VASP). PRI percent (%) was calculated using the median fluorescence intensity (MFI) of samples included with prostaglandin E1 (PGE1) and ADP, according to the following formula:

PRI%=[(MFI(PGE1)-MFI(PGE1 + ADP)/MFI(PGE1)]x100

Lower PRI% values indicate greater P2Y12 receptor blockade.

Posted

Mean

Standard Deviation

Percentage PRI

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

P2Y12 Reaction Units (PRU)

P2Y12 Reaction Units (PRU) assessed by Accumetrics Verify NowTM P2Y12. PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition.

Posted

Mean

Standard Deviation

PRU

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)

Poor responder is defined as MPA to 20 μM ADP >75th percentile of the value at 6-18 hours post-clopidogrel LD.

Posted

Number

Participants

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)

Maximum platelet aggregation to 20 μM ADP was assessed by LTA.

Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)

Posted

Mean

Standard Deviation

Percentage aggregation

Baseline to 6-18 hrs post loading dose (LD)

ID	Title	Description
OG000	Clopidogrel 900 mg	Clopidogrel 900 mg LD (a single or cumulative dose)

Units	Counts
Participants	OG00023

Secondary

Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)

Maximum platelet aggregation to 20 μM ADP was assessed by LTA.

Posted

Mean

Standard Deviation

Percentage aggregation

6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel/Clopidgrel	Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
OG001	Clopidogrel/Prasugrel	Clopidogrel (150-mg MD)or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)

Units	Counts
Participants	OG000

Secondary

MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)

Maximum platelet aggregation to 20 μM ADP was assessed by LTA.

Subjects providing evaluable MPA to 20 μM ADP at 14 days after the first maintenance dose (MD)

Posted

Mean

Standard Deviation

Percentage aggregation

14 days after the first maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel/Clopidogrel	Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
OG001	Clopidogrel/Prasugrel	Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)

Units	Counts
Participants	OG000

Secondary

MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)

Maximum platelet aggregation to 20 μM ADP was assessed by LTA.

Subjects providing evaluable MPA to 20 μM ADP at Day 29.

Posted

Mean

Standard Deviation

Percentage aggregation

14 days after the second maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel/Clopidogrel	Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
OG001	Clopidogrel/Prasugrel	Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria

Bleeding events will be classified as Major Bleeding, Minor Bleeding, or Insignificant Bleeding according to the TIMI criteria. Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 grams/deciliter (gm/dL) but <5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.

Posted

Number

Participants

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants

Secondary

Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)

Bleeding events will be classified according to the GUSTO definitions as follows: Severe or Life-Threatening Bleeding: any ICH OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Moderate Bleeding: any bleeding event resulting in the need for transfusion. Minor bleeding: any other bleeding event that does not require transfusion or cause hemodynamic compromise.

Posted

Number

Participants

14 days after maintenance dose (MD)

ID	Title	Description
OG000	Prasugrel	Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
OG001	Clopidogrel	Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)

Units	Counts
Participants	OG000

Secondary

Correlation of MPA to 20 μM ADP and PRU

Pearson-correlation estimated between MPA to 20 μM ADP and Accumetrics VerifyNowTM P2Y12 PRU

Posted

Number

Correlation coefficient

Baseline through 29 days of treatment

ID	Title	Description
OG000	Intent-to-treat Population	Both clopidogrel and prasugrel combined population

Units	Counts
Participants	OG00056

Title	Denominators

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Clopidogrel 900 mg LD	One time oral loading dose (LD) of 900-mg clopidogrel	1	56	20	56
EG001	Prasugrel 10 mg - 1st MD	Once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days.	3	29	7	29
EG002	Clopidogrel 150 mg - 1st MD	Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days.	0	25	7	25
EG003	Clopidogrel 150 mg - Crossover From Prasugrel 10 mg	Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of prasugrel 10 mg and 100 mg aspirin during the 1st MD period.	1	24	3	24
EG004	Prasugrel 10 mg - Crossover From Clopidogrel 150 mg	Once daily MD of prasugrel 10 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of clopidogrel 150 mg and 100 mg aspirin during the 1st MD period.	1	22	2	22

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG0030 events0 affected24 at risk EG0040 events0 affected22 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Retroperitoneal haematoma	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Septic shock	Infections and infestations	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG0030 events0 affected24 at risk EG0040 events0 affected22 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0002 events2 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Cardiac flutter	Cardiac disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0021 events1 affected25 at risk EG003
Pericarditis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0021 events1 affected25 at risk EG003
Ventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0003 events3 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0021 events1 affected25 at risk EG003
Eye haemorrhage	Eye disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0012 events2 affected29 at risk EG0020 events0 affected25 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Asthenia	General disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0012 events2 affected29 at risk EG0020 events0 affected25 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0003 events3 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Malaise	General disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Pain	General disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Puncture site haemorrhage	General disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Oxygen saturation decreased	Investigations	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected56 at risk EG0010 events0 affected29 at risk EG0021 events1 affected25 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Shoulder pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0005 events5 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0021 events1 affected25 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0021 events1 affected25 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0005 events5 affected56 at risk EG0011 events1 affected29 at risk EG0022 events2 affected25 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0011 events1 affected29 at risk EG0021 events1 affected25 at risk EG003
Cardioversion	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Flushing	Vascular disorders	Systematic Assessment	EG0000 events0 affected56 at risk EG0010 events0 affected29 at risk EG0021 events1 affected25 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0003 events3 affected56 at risk EG0010 events0 affected29 at risk EG0020 events0 affected25 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected56 at risk EG0011 events1 affected29 at risk EG0020 events0 affected25 at risk EG003

ID	Term
D054058	Acute Coronary Syndrome

ID	Term
D000068799	Prasugrel Hydrochloride
D000077144	Clopidogrel

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013988	Ticlopidine
D058924	Thienopyridines
D011725	Pyridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Title

Denominators

Categories

Title	Measurements
	OG000-35.5± 17.5

EG0040 events0 affected22 at risk

EG0041 events1 affected22 at risk

EG0040 events0 affected22 at risk

EG0041 events1 affected22 at risk

EG0040 events0 affected22 at risk

EG0041 events1 affected22 at risk

EG0040 events0 affected22 at risk

EG0041 events1 affected22 at risk

EG0040 events0 affected22 at risk

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases