Customized Choice of P2Y12 Oral Receptor Blocker Based on Phenotype Assessment Via Point of Care Testing (PRU-MATRIX)

NCT01477775 Phase 4 UNKNOWN

A subset of patients recruited in the main MATRIX study will be randomized after intervention but before discharge to standard of care (the treating physician will decide which oral P2Y12 inhibitor will be added on top of aspirin) versus a customized approach based on an algorithm which integrates phenotypic information, including but not limited to residual on-treatment platelet reactivity assessed via VerifyNow P2Y12 Assay.

Details

Lead sponsor	Italian Society of Invasive Cardiology
Phase	Phase 4
Status	UNKNOWN
Enrolment	4000
Start date	2012-01
Completion	2015-12

Conditions

• Acute Coronary Syndrome
• Coronary Angioplasty

Interventions

• Oral P2Y12 receptor blocker
• Customized choice for the oral P2Y12 receptor blocker

Primary outcomes

• Cardiovascular death, myocardial infarction, stroke or BARC defined bleeding type 2, 3 or 5 — 1 year
  The time to first occurrence of any of the variables listed above will be reported as primary study outcome.
• Proportion of patients in the therapeutic range for residual P2Y12 pathway activity according to PRU values. — 30 days
  We expect that the prospective use of the previously generated combined phenotype and genotype algorithm will result in an higher proportion of patients being in the therapeutic range with respect to the P2Y12 residual activity (70%) as compared to patients in who the P2Y12 inhibitor is left to the discretion of the treating physician. The first 320 patients recruited in the present study will participate into this mechanistic sub-study.

Countries

Italy