Coronary DiseasePhase 4(CAPP)NCT01431495
Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)
A Phase 4 study testing Pidogrel and Plavix in people with Coronary Disease, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
Trial summary
This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in patients with coronary disease: Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg loading dose or after the last maintenance dose (75 mg). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Pidogrel and Plavix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteTunisia
- Study dates
- Apr 2010to Jul 2011
- 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
- Male or female,
- Old (e) over 20 years
- Patients hospitalized for acute coronary syndrome (Whatever the T and troponin)
- Patients with proven coronary candidates for treatment with clopidogrel (who received a loading dose of 600mg over 2 hours and treated with 75mg / d of clopidogrel for longer than 7 days)
Who cannot join
- Patients unwilling.
- Patient participating in another study.
- Patients with cardiogenic shock
- Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
- Patients scheduled for surgery in less than 6 months.
- Patients candidates for coronary angioplasty
Show all 18Show fewer
- Patients who underwent TAC + / - bare stent fewer than 30 days.
- Patients who underwent stenting with ATC active there is less than 12 months.
- ischemic stroke older than 6 weeks.
- History of hemorrhagic stroke (any time)
- Patients on warfarin or candidates
- Patients with a different anti ADP (ticlopidine, prasugrel)
- Patients with indication for clopidogrel-cons (side effects, bleeding ...)
- Thrombocytopenia <100000/mm3
- anemia (Ht <30%)
- Thrombocythaemia (Ht> 52%)
- Patients seeking treatment for an elective forms of Clopidogrel.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
cardiology department, hospital La RABTA
Tunis, Tunis BAB Souika, 1007
About this study
Official title: Clinical Assessment of Pidogrel® Versus Plavix®
This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in patients with coronary disease:
- Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg loading dose or after the last maintenance dose (75 mg).
- Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events (MACE).
- Safety Criteria: severe bleeding (GUSTO scale).
Read the detailed description
after randomization of patients in both groups (Plavix or Pidogrel), the measure of platelet activity by the VerifyNow assay, 4 to 12 hours after the loading dose of 600mg or after the last dose of clopidogrel for patients on maintenance dose. The VerifyNow assay will determine: - The PRU:-P2Y12 Reaction Units-
-% Of platelet inhibition It will be considered low responder or clopidogrel resistant patient with PRU> 235 or %inhibition <15%.
Monitoring of patients included in the study will take place over a period of 12 months, MACE will be notified and dated. MACE criteria are: angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft, and stroke.
Each hemorrhagic event will be notified and classified according to the GUSTO scale.
- Conditions
- Coronary Disease
- Being tested
- Pidogrel, Plavix
- Keywords
- platelet agregation, clopidogrel, major adverse cardiac events (MACE)
- Medical subject headings
- Coronary Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PidogrelDrug
Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.
PlavixDrug
Plavix(R) 75 mg/day for period ranging from 1 to 6 months.
| Study group | Role | What they receive |
|---|---|---|
| plavix | Active comparator | patient treated by the princeps Receives: Drug: Plavix |
| Pidogrel | Active comparator | patient treated by Pidogrel Receives: Drug: Pidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
- study the respective effects of Pidogrel ® and Plavix ® on platelet aggregation through the test VerifyNow ® - Time to first occurrence of post-randomization major adverse cardiac events (MACE)
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachid MECHMECHE, MD, Study chair, hospital La RABTA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431495
- Sponsor's protocol ID
- CAPP-study
- Acronym
- (CAPP)
- Status last verified
- Sep 2011
- First submitted
- 25 Aug 2011
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Pidogrel® Versus Plavix®
- ClinicalTrials.gov ID
- NCT01431495
- Acronym / sponsor ID
- (CAPP) / CAPP-study
- Conditions
- Coronary Disease
- Keywords
- platelet agregation, clopidogrel, major adverse cardiac events (MACE)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 9 Sep 2011 (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 aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in patients with coronary disease:
- Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg loading dose or after the last maintenance dose (75 mg).
- Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events (MACE).
- Safety Criteria: severe bleeding (GUSTO scale).
Detailed description
after randomization of patients in both groups (Plavix or Pidogrel), the measure of platelet activity by the VerifyNow assay, 4 to 12 hours after the loading dose of 600mg or after the last dose of clopidogrel for patients on maintenance dose. The VerifyNow assay will determine: - The PRU:-P2Y12 Reaction Units-
-% Of platelet inhibition It will be considered low responder or clopidogrel resistant patient with PRU> 235 or %inhibition <15%.
Monitoring of patients included in the study will take place over a period of 12 months, MACE will be notified and dated. MACE criteria are: angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft, and stroke.
Each hemorrhagic event will be notified and classified according to the GUSTO scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plavix | Active comparator | Drug: Plavixpatient treated by the princeps |
| Pidogrel | Active comparator | Drug: Pidogrelpatient treated by Pidogrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female,
- Old (e) over 20 years
- Patients hospitalized for acute coronary syndrome (Whatever the T and troponin)
- Patients with proven coronary candidates for treatment with clopidogrel (who received a loading dose of 600mg over 2 hours and treated with 75mg / d of clopidogrel for longer than 7 days)
Key exclusion criteria (18 listed)
- Patients unwilling.
- Patient participating in another study.
- Patients with cardiogenic shock
- Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability
- Patients scheduled for surgery in less than 6 months.
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 |
|---|---|---|
| PidogrelPidogrel(R)75 mg/day for period ranging from 1 to 6 months. | Drug | Pidogrel |
| PlavixPlavix(R) 75 mg/day for period ranging from 1 to 6 months. | Drug | plavix |
Primary outcome
- study the respective effects of Pidogrel ® and Plavix ® on platelet aggregation through the test VerifyNow ® - Time to first occurrence of post-randomization major adverse cardiac events (MACE)
Time frame: 06 months
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 9 Sep 2011.
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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.
Rachid MECHMECHE, MD study chair
hospital La RABTA
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 Pidogrel and Plavix in people with Coronary Disease, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
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 4 inclusion and 18 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 9 Sep 2011. 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 Tunisia. 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?
- study the respective effects of Pidogrel ® and Plavix ® on platelet aggregation through the test VerifyNow ® - Time to first occurrence of post-randomization major adverse cardiac events (MACE) (time frame: 06 months). 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 9 Sep 2011.