Primary Reperfusion Secondary Stenting Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01542385
• Date of registration: 16/02/2012
• Prospective Registration: Yes
• Primary sponsor: Montreal Heart Institute
• Public title: Primary Reperfusion Secondary Stenting Trial PRIMACY
• Scientific title: Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction
• Date of first enrolment: April 2014
• Target sample size: 307
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01542385
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada, France

Contacts

• Name: Nandini Dendukuri, PhD
• Affiliation: Centre for Outcomes Research, McGill University Health Centre - Research Institute

• Name: Loic Belle, MD
• Affiliation: Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France

• Name: Marc E Jolicoeur, MD MSc MHS
• Affiliation: Montreal Heart Institute, Université de Montréal

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age between 18 and 80 years;

2. STEMI, presenting within 12 hours of symptoms onset, and persisting for more than 20
minutes;

3. ECG that fulfills any of the following criteria: = 2 mm ST elevation in two anterior
or lateral leads; or = 1 mm ST elevation in two inferior leads; or new left bundle
branch block (LBBB) with at least 1 mm concordant ST elevation;

4. Infarct-related artery with TIMI flow 0 or 1 at baseline angiogram;

5. Successful reperfusion (TIMI 2-3 flow), either spontaneously or after wire passage,
thrombectomy, small size (= 2.0mm) angioplasty catheter, and persisting for more than
10 minutes;

6. Infarct related artery with a diameter above 2.5 mm.

Exclusion Criteria:

1. Prior STEMI in the qualifying coronary artery;

2. Coronary dissection following reperfusion;

3. STEMI caused by acute stent thrombosis or a venous or arterial bypass graft occlusion;

4. Significant left main disease, as determined by angiography (= 50%) or other imaging
technologies;

5. Cardiac condition requiring emergent or urgent surgical repair;

6. Failed thrombolysis and rescue PCI;

7. High risk of bleeding;

8. Contraindication to either ticagrelor or GpIIb/IIIa inhibitors;

9. STEMI with Killip III-IV or cardiogenic shock or presenting as sudden death,
ventricular fibrillation, or sustained ventricular tachycardia;

10. Women who are pregnant or breastfeeding;

11. Creatinine clearance < 20 ml/min;

12. Other contraindication to PCI;

13. Participation with another investigational drug or investigational device study within
30 days prior to randomization (participation to registries is allowed);

14. Any condition that in the opinion of the investigator would preclude compliance with
the study protocol.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

ST-elevation Myocardial Infarction

Intervention(s)

Procedure: Stent

Primary Outcome(s)

The combined occurence of cardiac death, non-fatal myocardial infarction, congestive heart failure, and urgent target vessel revascularization [Time Frame: 9 months]

Secondary Outcome(s)

Major bleeding [Time Frame: 9 months]

Secondary ID(s)

PRIMACY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors