Coronary Artery DiseasePhase 4NCT01349777
Effectiveness of Clopidogrel Resinate in PCI(PRIDE)
A Phase 4 study testing Pregrel® and Plavix® in people with Coronary Artery Disease, run by Seung-Jung Park at 3 sites in South Korea.
Trial summary
This study is an open label, multi-center, randomized trial, which is designed to evaluate the efficacy and safety of clopidogrel derivative (Pregrel®) therapy for 12 months in patients undergoing PCI compared to conventional clopidogrel (Plavix®). 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?
- Pregrel® and Plavix®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,056 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 15 Mar 2010to 14 Mar 2017
- 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
- The patient must be at least 18 years of age.
- Patients with symptomatic coronary artery disease with objective evidence of ischemia (e.g. symptoms of angina pectoris, positive stress test results, or dynamic ECG changes).
- Patients are referred for PCI, or thought to be at high likelihood for requiring stent placement with or without conventional balloon angioplasty
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin
- Aspirin
- Both Clopidogrel and Ticlopidine
- Stainless steel and/or
- Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenylhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
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- Coronary anatomy not amenable to stent placement
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- An elective major surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Administration of the following medications prior to randomization: GpIIb-IIIa inhibitor and clopidogrel within 7 days (already received pretreatment), or thrombolytics within 24 hours.
- Long-term (at least > 3 months) use or requirement of NSAID or anticoagulation
- Patients with cardiogenic shock
- Acute MI patients within symptom onset < 12 hours needing primary angioplasty
- Patients with left main stem stenosis (>50% by visual estimate)
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Gangneung Asan Hospital
Gangneung
Asan Medical Center
Seoul, 138-736
Ulsan University Hospital
Ulsan
About this study
Official title: Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®)
This study is an open label, multi-center, randomized trial, which is designed to evaluate the efficacy and safety of clopidogrel derivative (Pregrel®) therapy for 12 months in patients undergoing PCI compared to conventional clopidogrel (Plavix®).
Read the detailed description
Prospective, two arms, randomized multi-center trial of 1,056 patients enrolled at 3 centers in Korea.
Following angiography, patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Pregrel® group vs. b) Plavix®. This trial is the non-inferiority study to demonstrate that the incidence of 12 months primary end-point in Pregrel® group.
- Conditions
- Coronary Artery Disease
- Being tested
- Pregrel®, Plavix®
- Keywords
- antiplatelet therapy post drug eluting stents
- 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.
Pregrel®Drug
Also called clopidogrel
Pregrel® 75mg daily for 12 months
Plavix®Drug
Also called clopidogrel 75mg
Plavix® 75mg daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Pregrel® | Experimental | clopidogrel Receives: Drug: Pregrel® |
| Plavix® | Active comparator | clopidogrel Receives: Drug: Plavix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke
Measured: 12 months
Secondary outcomes (17)
composite of death, MI, stroke, or urgent revascularization
Measured: 12 months
Individual components of death, MI, stroke, or urgent revascularization
Measured: at discharge
The need for target vessel revascularization or any revascularization
Measured: 12 months
The incidence of early discontinuation of study drugs
Measured: 30 days
The incidence of major bleeding events
Measured: 30 days
Stent thrombosis
Measured: 30 days
composite of death, MI, stroke, or urgent revascularization
Measured: 30 days
composite of death, MI, stroke, or urgent revascularization
Measured: 6 months
Individual components of death, MI, stroke, or urgent revascularization
Measured: 30 days
Individual components of death, MI, stroke, or urgent revascularization
Measured: 6 months
Individual components of death, MI, stroke, or urgent revascularization
Measured: 12 months
The incidence of major bleeding events
Measured: 6 months
The incidence of major bleeding events
Measured: 12 months
The incidence of early discontinuation of study drugs
Measured: 6 months
The incidence of early discontinuation of study drugs
Measured: 12 months
Stent thrombosis
Measured: 6 months
Stent thrombosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study start15 Mar 2010
- Primary completion14 Mar 2017
- Study completion14 Mar 2017
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Seung-Jung Park, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349777
- Sponsor's protocol ID
- 2009-0483
- Status last verified
- Jun 2017
- First submitted
- 22 Apr 2011
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®)
- ClinicalTrials.gov ID
- NCT01349777
- Acronym / sponsor ID
- 2009-0483
- Conditions
- Coronary Artery Disease
- Keywords
- antiplatelet therapy post drug eluting stents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,056 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 15 Mar 2010 (actual)
- Primary completion
- 14 Mar 2017 (actual)
- Study completion
- 14 Mar 2017 (actual)
- First posted
- 9 May 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 is an open label, multi-center, randomized trial, which is designed to evaluate the efficacy and safety of clopidogrel derivative (Pregrel®) therapy for 12 months in patients undergoing PCI compared to conventional clopidogrel (Plavix®).
Detailed description
Prospective, two arms, randomized multi-center trial of 1,056 patients enrolled at 3 centers in Korea.
Following angiography, patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Pregrel® group vs. b) Plavix®. This trial is the non-inferiority study to demonstrate that the incidence of 12 months primary end-point in Pregrel® group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregrel® | Experimental | Drug: Pregrel®clopidogrel |
| Plavix® | Active comparator | Drug: Plavix®clopidogrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must be at least 18 years of age.
- Patients with symptomatic coronary artery disease with objective evidence of ischemia (e.g. symptoms of angina pectoris, positive stress test results, or dynamic ECG changes).
- Patients are referred for PCI, or thought to be at high likelihood for requiring stent placement with or without conventional balloon angioplasty
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (19 listed)
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Coronary anatomy not amenable to stent placement
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 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 |
|---|---|---|
| Pregrel®Also: clopidogrelPregrel® 75mg daily for 12 months | Drug | Pregrel® |
| Plavix®Also: clopidogrel 75mgPlavix® 75mg daily for 12 months | Drug | Plavix® |
Primary outcome
composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke
Time frame: 12 months
17 secondary outcomes
composite of death, MI, stroke, or urgent revascularization
Time frame: 12 months
Individual components of death, MI, stroke, or urgent revascularization
Time frame: at discharge
The need for target vessel revascularization or any revascularization
Time frame: 12 months
The incidence of early discontinuation of study drugs
Time frame: 30 days
The incidence of major bleeding events
Time frame: 30 days
Stent thrombosis
Time frame: 30 days
composite of death, MI, stroke, or urgent revascularization
Time frame: 30 days
composite of death, MI, stroke, or urgent revascularization
Time frame: 6 months
Individual components of death, MI, stroke, or urgent revascularization
Time frame: 30 days
Individual components of death, MI, stroke, or urgent revascularization
Time frame: 6 months
Individual components of death, MI, stroke, or urgent revascularization
Time frame: 12 months
The incidence of major bleeding events
Time frame: 6 months
The incidence of major bleeding events
Time frame: 12 months
The incidence of early discontinuation of study drugs
Time frame: 6 months
The incidence of early discontinuation of study drugs
Time frame: 12 months
Stent thrombosis
Time frame: 6 months
Stent thrombosis
Time frame: 12 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 16 Jun 2017.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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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.
Seung-Jung Park, MD, PhD principal investigator
Asan Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregrel® and Plavix® in people with Coronary Artery Disease, run by Seung-Jung Park at 3 sites in South Korea.
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 19 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke (time frame: 12 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 16 Jun 2017.