NCT01341964

Brief Summary

Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
10.3 years until next milestone

Results Posted

Study results publicly available

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

September 1, 2022

Enrollment Period

1.9 years

First QC Date

April 25, 2011

Results QC Date

September 12, 2022

Last Update Submit

September 12, 2022

Conditions

Drug Action Increased

Keywords

ClopidogrelAspirinInteraction

Outcome Measures

Primary Outcomes (1)

  • Blood Concentration of the Active Metabolite of Clopidogrel

    Clopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods.

    1 hour after loading dose of study medications

Study Arms (2)

Higher dose aspirin group

EXPERIMENTAL

Clopidogrel 600 mg plus aspirin 325mg

Drug: ClopidogrelDrug: Aspirin

Low dose aspirin group

ACTIVE COMPARATOR

Clopidogrel 600mg plus aspirin 81mg

Drug: ClopidogrelDrug: Aspirin

Interventions

ClopidogrelDRUG

600mg (2 pills)

Also known as: Plavix
Higher dose aspirin groupLow dose aspirin group
AspirinDRUG

325mg (1 pill)

Also known as: Novasen
Higher dose aspirin group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable patients \>1 month post ACS (including ST elevated myocardial infarction, non-ST elevated myocardial infarction or unstable angina) or stent
  • Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
  • Written informed consent

You may not qualify if:

  • Age \< 18 years
  • Liver disease with ALT or bilirubin \>2x upper limits of normal (ULN)\*
  • Renal impairment with creatinine clearance \<30 ml/min\*
  • Deemed to be at high risk of bleeding (e.g., recent bleeding, platelet count\<100x109/L or hemoglobin \<100g/L)\*
  • Anticoagulant or NSAID therapy within the last 5 days
  • Antiplatelet agent other than aspirin and clopidogrel within the last 10 days
  • Uncontrolled hypertension (\>=180/110mmHg)
  • within 3 months of planned randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Population Health Research Institute, Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

  • Liang Y, Hirsh J, Weitz JI, Sloane D, Gao P, Pare G, Zhu J, Eikelboom JW. Active metabolite concentration of clopidogrel in patients taking different doses of aspirin: results of the interaction trial. J Thromb Haemost. 2015 Mar;13(3):347-52. doi: 10.1111/jth.12829. Epub 2015 Feb 4.

    PMID: 25557828DERIVED

MeSH Terms

Interventions

ClopidogrelAspirin

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Lynda Hill
Organization
Population Health Reseach Institute, Hamilton, ON, Canada
Lynda.Hill@phri.ca
905-297-3479

Study Officials

  • Yan Liang, MD

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

  • John Eikelboom, MD

    Population Health Research Institute

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 25, 2011

First Posted

April 26, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 27, 2023

Results First Posted

July 27, 2023

Record last verified: 2022-09

Locations

CA(1)