Primary Reperfusion Secondary Stenting Trial (PRIMACY)
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Purpose
The PRIMACY trial seeks to assess whether a strategy of delayed stent implantation combined with adjunctive anticoagulation is superior to immediate stent implantation at improving cardiovascular outcomes in patients with mechanically reperfused ST-elevation Myocardial Infarction (STEMI). The investigators hypothesize that delayed stent implantation combined with systemic anticoagulation and maximal antiplatelet therapy will reduce the combined occurrence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and target vessel revascularization at 90 days.
| Condition | Intervention | Phase |
|---|---|---|
|
ST-elevation Myocardial Infarction |
Procedure: Percutaneous coronary intervention |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction |
- The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization [ Time Frame: 90 days ] [ Designated as safety issue: No ]As defined by standardized definitions
- Major bleeding [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]As defined by the Bleeding Academic Research Consortium (BARC).
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Immediate stenting |
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting
Other Names:
|
| Experimental: Delayed stenting |
Procedure: Percutaneous coronary intervention
Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 18 and 80 years;
- ST-segment elevation myocardial infarction, presenting within 6 hours of symptoms onset, and persisting for more than 20 minutes;
High-risk STEMI as indicated by an ECG that fulfills any of the following three criteria:
- ≥ 2 mm ST elevation in two anterior or lateral leads; or
- ≥ 2 mm ST elevation in two inferior leads coupled with ST depression in two contiguous anterior leads for a total ST deviation of ≥ 8 mm; or
- New left bundle branch block (LBBB) with at least 1 mm concordant ST elevation
- Successful reperfusion (TIMI 3 flow) with a minimally invasive mechanical device (wire, thrombectomy, small size angioplasty catheter) persisting for more than 10 minutes
- Infarct-related artery with a diameter above 2.5 mm.
Exclusion Criteria:
- Prior STEMI in the qualifying artery;
- Coronary dissection following reperfusion;
- STEMI caused by acute stent thrombosis or a venous or arterial bypass graft occlusion;
- Significant left main disease, as determined by angiography (≥ 50%) or other imaging technologies;
- Cardiac condition requiring emergent or urgent surgical repair;
- High risk of bleeding (need for systemic anticoagulation with vitamin K antagonist or other agents, severe thrombocytopenia, diathesis);
- Contraindication to either ticagrelor, prasugrel or GpIIbIIIa inhibitors; including if prasugrel is selected age ≥ 75 years if , body weight < 60 kg and prior transient ischemic attacks, stroke, or intracranial hemorrhage;
- STEMI with Killip III-IV or cardiogenic shock;
- STEMI presenting with sudden death, ventricular fibrillation, or sustained ventricular tachycardia;
- Pregnant or breastfeeding;
- Chronic renal insufficiency (creatinine clearance < 50ml/min);
- Contra-indication to percutaneous coronary intervention (severe uncontrolled iodine allergy, no vascular access available, intolerance to P2Y12 inhibitors);
- Previous heart transplantation;
- Any other conditions which in the opinion of the investigator, may either put the subject at risk or influence the result of the study (active cancer, risk for non-compliance, and risk for being lost to follow up);
- Participation in another investigational drug or device study in the last 30 days.
Contacts and Locations| Contact: Marc E Jolicoeur, MD MSc MHS | 514-376-3330 | marc.jolicoeur@icm-mhi.org |
| Contact: Nathalie St-Jean | 514-376-3330 ext 3621 | nathalie.st-jean@icm-mhi.org |
| Study Chair: | Marc E Jolicoeur, MD MSc MHS | Montreal Heart Institute, Université de Montréal |
| Study Director: | Lawrence Joseph, PhD | McGill University Health Center |
| Study Director: | Jean-Caude Tardif, MD | Montreal Heart Institute, Université de Montréal |
More Information
Additional Information:
No publications provided
| Responsible Party: | Marc Jolicoeur, E. Marc Jolicoeur, MD MSc MHS FRCP-C FACC, Montreal Heart Institute |
| ClinicalTrials.gov Identifier: | NCT01542385 History of Changes |
| Other Study ID Numbers: | PRIMACY |
| Study First Received: | February 16, 2012 |
| Last Updated: | March 1, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Montreal Heart Institute:
|
Delayed stenting Deferred stenting Late stenting postponed stenting Thrombectomy |
Percutaneous coronary intervention PCI Angioplasty STEMI acute myocardial infarction |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013