Coronary Artery DiseasePhase 4INTERACTIONNCT01102439
Clopidogrel/Aspirin Interaction Study
A Phase 4 study testing Clopidogrel and Aspirin in people with Coronary Artery Disease, run by Population Health Research Institute at 1 site in Canada.
Trial summary
This study will explore the effect of different doses of aspirin on the effects of double-dose or standard dose clopidogrel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Factorial Study to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent
This study will explore the effect of different doses of aspirin on the effects of double-dose or standard dose clopidogrel.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel, Aspirin
- Keywords
- Clopidogrel, Aspirin, Interaction
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Plavix
300 mg loading dose, then 75 mg daily
ClopidogrelDrug
Also called Plavix
600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily
AspirinDrug
Also called Entrophen
81 mg daily
AspirinDrug
Also called Novasen
325 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Standard dose clopidogrel | Active comparator | 300 mg Loading x 1 day, 75 mg/d x 13 days Receives: Drug: Clopidogrel |
| Double dose clopidogrel | Experimental | 600 mg Loading x 1 day, 150 mg/d x 6 days, 75 mg/d x 7 days Receives: Drug: Clopidogrel |
| Standard dose aspirin | Active comparator | Aspirin 81mg/d x 14 days Receives: Drug: Aspirin |
| High dose aspirin | Experimental | Aspirin 325 mg/d x 14 days Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentrations of the active metabolite of clopidogrel
Measured: 14 days
Secondary outcomes (1)
Inhibition of adenosine diphosphate (ADP) induced platelet aggregation
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Eikelboom, Population Health Research Institute
- Investigators
- Yan Liang, MD, Principal investigator, Population Health Research InstituteJohn Eikelboom, MD., Study director, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102439
- Sponsor's protocol ID
- 10-082
- Acronym
- INTERACTION
- Status last verified
- Apr 2015
- First submitted
- 8 Apr 2010
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Factorial Study to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent
- ClinicalTrials.gov ID
- NCT01102439
- Acronym / sponsor ID
- INTERACTION / 10-082
- Conditions
- Coronary Artery Disease
- Keywords
- Clopidogrel, Aspirin, Interaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard dose clopidogrel | Active comparator | Drug: Clopidogrel300 mg Loading x 1 day, 75 mg/d x 13 days |
| Double dose clopidogrel | Experimental | Drug: Clopidogrel600 mg Loading x 1 day, 150 mg/d x 6 days, 75 mg/d x 7 days |
| Standard dose aspirin | Active comparator | Drug: AspirinAspirin 81mg/d x 14 days |
| High dose aspirin | Experimental | Drug: AspirinAspirin 325 mg/d x 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelAlso: Plavix300 mg loading dose, then 75 mg daily | Drug | Standard dose clopidogrel |
| ClopidogrelAlso: Plavix600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily | Drug | Double dose clopidogrel |
| AspirinAlso: Entrophen81 mg daily | Drug | Standard dose aspirin |
| AspirinAlso: Novasen325 mg daily | Drug | High dose aspirin |
Primary outcome
Blood concentrations of the active metabolite of clopidogrel
Time frame: 14 days
1 secondary outcome
Inhibition of adenosine diphosphate (ADP) induced platelet aggregation
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Liang, MD principal investigator
Population Health Research Institute
John Eikelboom, MD. study director
Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel and Aspirin in people with Coronary Artery Disease, run by Population Health Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood concentrations of the active metabolite of clopidogrel (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.