Clopidogrel/Aspirin Interaction Study | NCT01102439

Studies
Clopidogrel/Aspirin Interaction Study

NCT01102439

Sponsor

Population Health Research Institute

Status

Completed

Last Update Posted

Apr 28, 2015Estimated

Enrollment

82Actual

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Clopidogrel
Clopidogrel
Aspirin
Aspirin

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

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

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Feb 2013Actual

First Submitted Date

Apr 8, 2010

First Submission Date that Met QC Criteria

Apr 12, 2010

First Posted Date

Apr 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2015

Last Update Posted Date

Apr 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will explore the effect of different doses of aspirin on the effects of double-dose or standard dose clopidogrel.

Detailed Description

Study Hypothesis: Patients receiving double-dose compared with standard-dose clopidogrel will have increased blood concentrations of the active metabolite of clopidogrel and greater inhibition of ADP-induced platelet aggregation when also treated with acetylsalicylic acid (ASA) 325 mg/d as compared to ASA 81 mg/d.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard dose clopidogrel	Active Comparator	300 mg Loading x 1 day, 75 mg/d x 13 days	Drug: Clopidogrel
Double dose clopidogrel	Experimental	600 mg Loading x 1 day, 150 mg/d x 6 days, 75 mg/d x 7 days	Drug: Clopidogrel
Standard dose aspirin	Active Comparator	Aspirin 81mg/d x 14 days	Drug: Aspirin
High dose aspirin	Experimental	Aspirin 325 mg/d x 14 days	Drug: Aspirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clopidogrel	Drug	300 mg loading dose, then 75 mg daily	Standard dose clopidogrel

Measure	Description	Time Frame
Blood concentrations of the active metabolite of clopidogrel		14 days

Measure	Description	Time Frame
Inhibition of adenosine diphosphate (ADP) induced platelet aggregation		14 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 1 month post myocardial infarction (MI), unstable angina or stent patients with stable condition
Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
Written informed consent

Exclusion Criteria:

Age < 18 years old
Liver disease with transaminases and/or bilirubin > 1.5x upper limits of normal (ULN) (within 3 months of randomization)
Renal impairment with creatinine clearance < 30 ml/min (within 3 months of randomization)
Platelet count < 100x109/L and/or Hb< 100g/L (within 3 months of randomization)
Use of oral anticoagulants or nonsteroidal antiinflammatory drug (NSAID) within the last 10 days or planned use during the study
Use of antiplatelet agent other than aspirin and clopidogrel within the last 10 days
High risk of bleeding (e.g. recent gastrointestinal bleeding, bleeding diathesis)
Uncontrolled hypertension (> 180/110mmHg)
Current smoker with ≥ 5 cigarettes/day
Previously entered in this study or just finished other study within 2 weeks before recruitment
Medical, geographic, or social factors making study participation impractical, or inability to provide written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yan Liang, MD	Population Health Research Institute	Principal Investigator
John Eikelboom, MD.	Population Health Research Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Population Health Research Institute		Hamilton	Ontario	L8L 2X2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds