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The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American patients with stable coronary artery disease.
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in African American Patients with Stable Coronary Artery Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ticagrelor | Experimental |
| |
| Clopidogrel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Min - 90mg/Max - 180mg tablets (loading dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose | At 2 hours after the loading dose |
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose | At 0.5 hour and 8 hours after the loading dose | |
| Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Carlson, MD | AstraZeneca Pharmaceuticals Room C3B-718PO Box 15437 Wilmington, DE 19850-5437 USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Newark | Delaware | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26152562 | Derived | Waksman R, Maya J, Angiolillo DJ, Carlson GF, Teng R, Caplan RJ, Ferdinand KC. Ticagrelor Versus Clopidogrel in Black Patients With Stable Coronary Artery Disease: Prospective, Randomized, Open-Label, Multiple-Dose, Crossover Pilot Study. Circ Cardiovasc Interv. 2015 Jul;8(7):e002232. doi: 10.1161/CIRCINTERVENTIONS.114.002232. |
| Label | URL |
|---|---|
| D5130L00013\_Study\_Synopsis | View source |
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50 patients screened; 34 patients randomized; 30 patients completed the study (7, 8, or 9 days of both treatments), and 31 completed follow-up
Patients recruited from 8 participating centers in the United States from 28 March 2012 until 04 September 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence | Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2) |
| FG001 | Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence | Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
| |||||||||||||||||||||
| Washout Period - 10 to 14 Days |
| ||||||||||||||||||||||
| Treatment Period 2 |
|
Randomized Analysis Set for demography (N=34) - included all patients who signed informed consent and were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence | Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 2) |
| BG001 | Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose | Pharmacodynamic (PD) Analysis Set (N=32) - included all participants for whom PD data was available with no major protocol deviations thought to significantly affect the PD of ticagrelor or clopidogrel | Least Squares Mean | 95% Confidence Interval | PRU | At 2 hours after the loading dose |
|
Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant).
Adverse events were solicited at each scheduled visit and could be reported by the participant at any time during the study. When summarizing Treatment Period 1 and Treatment Period 2 totals, each participant was counted only once for an individual adverse event, regardless of whether it occurred on ticagrelor, clopidogrel or both.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ticagrelor | Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA V16.0 | Systematic Assessment | Occurred 14 days after the last dose of ticagrelor |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorroidal haemorrhage | Gastrointestinal disorders | MedDRA V16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tomas LG Andersson, MD, PhD | AstraZeneca | 1-800-236-9933 | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Clopidogrel |
| Drug |
75mg (once daily)/Max - 600mg tablets (loading dose) |
|
| At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8 |
| Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses | The standard deviation (SD) is the geometric SD | Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose |
| AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses | The standard deviation (SD) is the geometric SD | Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose |
| Wilmington |
| Delaware |
| United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Hollywood | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Towson | Maryland | United States |
| Research Site | Beaumont | Texas | United States |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
|
|
|
| Secondary | Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose | PD Analysis Set | Least Squares Mean | 95% Confidence Interval | PRU | At 0.5 hour and 8 hours after the loading dose |
|
|
|
|
| Secondary | Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8 | PD Analysis Set | Least Squares Mean | 95% Confidence Interval | PRU | At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8 |
|
|
|
|
| Secondary | Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses | The standard deviation (SD) is the geometric SD | Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available | Geometric Mean | Standard Deviation | ng/mL | Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose |
|
|
|
| Secondary | AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses | The standard deviation (SD) is the geometric SD | Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available | Geometric Mean | Standard Deviation | ng/mL | Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose |
|
|
|
| 1 |
| 34 |
| 5 |
| 34 |
| EG001 | Clopidogrel | Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days | 0 | 31 | 2 | 31 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA V16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V16.0 | Systematic Assessment |
|
| Application site bruise | General disorders | MedDRA V16.0 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA V16.0 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA V16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA V16.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA V16.0 | Systematic Assessment |
|
| Vaginal haemmorhage | Reproductive system and breast disorders | MedDRA V16.0 | Systematic Assessment |
|
An Investigator agrees to provide a copy of the publication to AstraZeneca (AZ) for review at least 60 days in advance of the submission for publication. The Investigators in the Multi-Center (MC) study agree to postpone MC publications until the earlier of the first AstraZeneca-authorized publication or up to eighteen months from study completion at all sites.
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Analysis at 8 hours after loading dose | Mixed Models Analysis | Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence | <0.001 | Mean Difference (Final Values) | -165.3 | Standard Error of the Mean | 15.45 | 2-Sided | 95 | -197.4 | -133.3 | Ticagrelor minus clopidogrel | No | Superiority or Other |
| End of dosing interval on Day 8 |
|
| Analysis at 8 hours on Day 7 after multiple doses | Mixed Models Analysis | Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence | <0.001 | Mean Difference (Final Values) | -118.1 | Standard Error of the Mean | 12.55 | 2-Sided | 95 | -143.9 | -92.2 | Ticagrelor minus clopidogrel | No | Superiority or Other |
| Analysis at end of dosing interval on Day 8 | Mixed Models Analysis | Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence | <0.001 | Mean Difference (Final Values) | -133.4 | Standard Error of the Mean | 12.77 | 2-Sided | 95 | -159.7 | -107.1 | Ticagrelor minus clopidogrel | No | Superiority or Other |
| 2 hours after the loading dose |
|
| 8 hours after the loading dose - Period 1 N=19 |
|
| 0 hours after multiple doses - Period 1 N=18 |
|
| 2 hours after multiple doses - Period 1 N=18 |
|
| 8 hours after multiple doses - Period 1 N=18 |
|
| End of dosing interval on Day 8 - Period 1 N=18 |
|
| 2 hours after the loading dose |
|
| 8 hours after the loading dose - Period 1 N=19 |
|
| 0 hours after multiple doses - Period 1 N=18 |
|
| 2 hours after multiple doses - Period 1 N=18 |
|
| 8 hours after multiple doses - Period 1 N=18 |
|
| End of dosing interval on Day 8 - Period 1 N=18 |
|