Drug Action IncreasedPhase 4Interaction2NCT01341964

Clopidogrel and Aspirin Interaction Study-2

A Phase 4 study testing Clopidogrel and Aspirin in people with Drug Action Increased, run by Population Health Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Drug Action Increased
What is being tested?: Clopidogrel and Aspirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 302 participants
Where: 1 siteCanada
Study dates: May 2011to Apr 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Population Health Research Institute, Hamilton General Hospital
Hamilton, Ontario, L8L 2X2

Other trials in Canada

About this study

Official title: Randomized Controlled Trial to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent

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.

Read the detailed description

Eligible patients will be randomized to receive clopidogrel 600mg + aspirin 325mg (Group A) or clopidogrel 600mg + aspirin 81mg (Group B). Patients will be fasted for at least 8 hours prior to study drug administration. Blood samples will be collected at 1 hour after study drug administration for measurement of clopidogrel active metabolite levels and genotyping.

Conditions: Drug Action Increased
Being tested: Clopidogrel, Aspirin
Keywords: Clopidogrel, Aspirin, Interaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClopidogrelDrug
Also called Plavix
600mg (2 pills)
AspirinDrug
Also called Novasen
325mg (1 pill)
AspirinDrug
Also called Entrophen
81mg (1 pill)

Study groups in NCT01341964
Study group	Role	What they receive
Higher dose aspirin group	Experimental	Clopidogrel 600 mg plus aspirin 325mg Receives: Drug: Clopidogrel; Drug: Aspirin
Low dose aspirin group	Active comparator	Clopidogrel 600mg plus aspirin 81mg Receives: Drug: Clopidogrel; Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Concentration of the Active Metabolite of Clopidogrel
Clopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods.
Measured: 1 hour after loading dose of study medications

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Apr 2013

First posted26 Apr 2011 (estimated)
Study startMay 2011
Primary completionApr 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Drug Action IncreasedStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01341964
Sponsor's protocol ID: 11-090
Acronym: Interaction2
Status last verified: Sep 2022
First submitted: 25 Apr 2011
Last updated: 27 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25557828

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial to Explore Interaction Between Aspirin and Clopidogrel in Stable Patients With Previous Myocardial Infarction or Coronary Artery Stent
ClinicalTrials.gov ID: NCT01341964
Acronym / sponsor ID: Interaction2 / 11-090
Conditions: Drug Action Increased
Keywords: Clopidogrel, Aspirin, Interaction
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Population Health Research InstituteUniversity, hospital or other
Study start: May 2011
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 26 Apr 2011 (estimated)
Results: Posted 27 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Higher dose aspirin group	Experimental	Drug: Clopidogrel, Drug: AspirinClopidogrel 600 mg plus aspirin 325mg
Low dose aspirin group	Active comparator	Drug: Clopidogrel, Drug: AspirinClopidogrel 600mg plus aspirin 81mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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

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: Plavix600mg (2 pills)	Drug	Higher dose aspirin group, Low dose aspirin group
AspirinAlso: Novasen325mg (1 pill)	Drug	Higher dose aspirin group
AspirinAlso: Entrophen81mg (1 pill)	Drug	Low dose aspirin group

Primary outcome

Blood Concentration of the Active Metabolite of Clopidogrel
Time frame: 1 hour after loading dose of study medications
Clopidogrel active metabolite concentration will be measured by liquid chromatography tandem mass spectrometry (LC/MS) methods.

Results and safety

Results posted to the registry on 27 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Higher Dose Aspirin Group	152	152
Low Dose Aspirin Group	150	150

Primary outcome: Blood Concentration of the Active Metabolite of Clopidogrel

Time frame: 1 hour after loading dose of study medications. Median (Inter-Quartile Range). Unit: ng/ml

Measure	Clopidogrel Concentration of Higher Dose Aspirin Group n = 147	Clopidogrel Concentration of Low Dose Aspirin Group n = 143
Value	14.45 (6.58 to 24.20)	13.80 (7.62 to 20.20)

Clopidogrel Concentration of Higher Dose Aspirin Group vs Clopidogrel Concentration of Low Dose Aspirin Group: Median Difference (Final Values): 0.05, p = 0.66, t-test, 2 sided

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clopidogrel Concentration of Higher Dose Aspirin Group	0 of 152 (0%)	0 of 152 (0%)	0 of 152
Clopidogrel Concentration of Low Dose Aspirin Group	0 of 150 (0%)	0 of 150 (0%)	0 of 150

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25557828Liang 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.

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 Drug Action Increased, 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 8 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 27 Jul 2023. 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?

Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Concentration of the Active Metabolite of Clopidogrel (time frame: 1 hour after loading dose of study medications). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01341964, which also lists 1 linked publication.

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 27 Jul 2023.