Coronary Artery DiseasePhase 3NCT00693069
Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function
A Phase 3 study testing Clopidogrel in people with Coronary Artery Disease, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces peri-procedural and long-term ischemic complications. Documented reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Apr 2006
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient with an indication for elective coronary angiography with or without PCI
Who cannot join
- major hemorrhagic diathesis or active bleeding
- acute myocardial infarction (MI) within 14 days of enrolment
- unstable angina with ST-segment changes >1 mm in at least two contiguous electrocardiographic leads at rest or a troponin I level >0.06 microg/L within 14 days of enrolment
- stroke within the past 3 months
- platelet count <100 x 10 9/L
- prothrombin time > 1.5 times control
Show all 11Show fewer
- hematocrit <25% or hemoglobin level <100 g/L
- alcohol or drug abuse
- enrolment in other investigational drug trials within the previous month
- use of thienopyridines, glycoprotein (GP) IIb/IIIa inhibitors, warfarin or acenocoumarol within the previous week
- allergic reaction or any contraindication to clopidogrel or aspirin administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function
Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces peri-procedural and long-term ischemic complications. Documented reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. Strategies to optimize platelet inhibition pre-PCI are under investigation.
This study sought to evaluate the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective PCI.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel
- Keywords
- angioplasty, clopidogrel, coronary artery disease, platelets, Percutaneous coronary intervention
- 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
clopidogrel 300 mg on the day prior to angiography
ClopidogrelDrug
clopidogrel 600 mg on the day prior to angiography
ClopidogrelDrug
clopidogrel 300 mg followed by 75 mg daily started one week prior to angiography
ClopidogrelDrug
clopidogrel 300 mg followed by 150 mg daily started one week prior to angiography
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Clopidogrel 300 mg the day before PCI Receives: Drug: Clopidogrel |
| 2 | Experimental | Clopidogrel 600 mg the day before PCI Receives: Drug: Clopidogrel |
| 3 | Experimental | 300 mg followed by 75 mg daily started one week prior to angiography Receives: Drug: Clopidogrel |
| 4 | Experimental | 300 mg followed by 150 mg daily started one week prior to angiography Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study was to evaluate the effect of four different dosing regimens of clopidogrel on platelet aggregation at the time of diagnostic coronary angiography, and 2 hours after stenting.
Measured: 7 days
Secondary outcomes (1)
A secondary objective in patients stented was the 30-day incidence of the composite of death, myocardial infarction (MI) or urgent target vessel revascularization.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startSep 2004
- Study completionApr 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Investigators
- Jean G Diodati, MD, Principal investigator, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693069
- Sponsor's protocol ID
- C.E.2004-06-24A
- Status last verified
- Jun 2008
- First submitted
- 3 Jun 2008
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Dosing Regimens of Clopidogrel Given Before Elective Percutaneous Coronary Intervention on Platelet Function
- ClinicalTrials.gov ID
- NCT00693069
- Acronym / sponsor ID
- C.E.2004-06-24A
- Conditions
- Coronary Artery Disease
- Keywords
- angioplasty, clopidogrel, coronary artery disease, platelets, Percutaneous coronary intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Apr 2006 (actual)
- First posted
- 6 Jun 2008 (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.
Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces peri-procedural and long-term ischemic complications. Documented reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. Strategies to optimize platelet inhibition pre-PCI are under investigation.
This study sought to evaluate the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ClopidogrelClopidogrel 300 mg the day before PCI |
| 2 | Experimental | Drug: ClopidogrelClopidogrel 600 mg the day before PCI |
| 3 | Experimental | Drug: Clopidogrel300 mg followed by 75 mg daily started one week prior to angiography |
| 4 | Experimental | Drug: Clopidogrel300 mg followed by 150 mg daily started one week prior to angiography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient with an indication for elective coronary angiography with or without PCI
Key exclusion criteria (11 listed)
- major hemorrhagic diathesis or active bleeding
- acute myocardial infarction (MI) within 14 days of enrolment
- unstable angina with ST-segment changes >1 mm in at least two contiguous electrocardiographic leads at rest or a troponin I level >0.06 microg/L within 14 days of enrolment
- stroke within the past 3 months
- platelet count <100 x 10 9/L
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 |
|---|---|---|
| Clopidogrelclopidogrel 300 mg on the day prior to angiography | Drug | 1 |
| Clopidogrelclopidogrel 600 mg on the day prior to angiography | Drug | 2 |
| Clopidogrelclopidogrel 300 mg followed by 75 mg daily started one week prior to angiography | Drug | 3 |
| Clopidogrelclopidogrel 300 mg followed by 150 mg daily started one week prior to angiography | Drug | 4 |
Primary outcome
The primary objective of this study was to evaluate the effect of four different dosing regimens of clopidogrel on platelet aggregation at the time of diagnostic coronary angiography, and 2 hours after stenting.
Time frame: 7 days
1 secondary outcome
A secondary objective in patients stented was the 30-day incidence of the composite of death, myocardial infarction (MI) or urgent target vessel revascularization.
Time frame: 30 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 21 Aug 2012.
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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.
Jean G Diodati, MD principal investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clopidogrel in people with Coronary Artery Disease, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal 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 1 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 21 Aug 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary objective of this study was to evaluate the effect of four different dosing regimens of clopidogrel on platelet aggregation at the time of diagnostic coronary angiography, and 2 hours after stenting. (time frame: 7 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 21 Aug 2012.