Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI

Study Overview
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Brief Summary
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Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)

Detailed Description
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Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.

Official Title
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Randomized Trial to Evaluate Effect of Adjunctive Antiplatelet Therapy With Intravenous PRT060128, a Selective P2Y12-Receptor Inhibitor, Before Primary Percutaneous Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) Patients

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: placebo
* Drug: PRT060128 Potassium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent ST elevation ≥ 1mm (≥ 0.1mV) in two contiguous limb leads OR ≥ 2 mm (≥ 0.2mV) in two contiguous precordial leads, AND chest pain ≥ 20 minutes with onset within 6 hours of hospital presentation. Exclusion Criteria: Cardiogenic shock (systolic blood pressure < 90 mm Hg requiring vasopressor or hemodynamic support) Uncontrolled hypertension defined as any measured systolic blood pressure (SBP) > 180 mm Hg or diastolic blood pressure (DBP) ≥ 110 mm Hg after the time -- History or symptoms of a congenital or acquired bleeding disorder or vascular malformation. Recent gastrointestinal bleeding within the last 30 days. Known thrombocytopenia (platelet count < 100,000/mm3). Any treatment with a fibrinolytic agent within the last 7 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo for each Dose cohort: 10, 20, 40, and 60 mg | Drug: placebo<br>* administration of iv bolus prior to angiography<br>|
| Experimental: 2<br>Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg | Drug: PRT060128 Potassium<br>* administration of iv bolus prior to angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days | TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit. TIMI Minor:Hemoglobin concentration decreased by 3g/dL (but <5g/dL) or the hematocrit decreased by 10-15%. GUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention. GUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention. Stroke:New focal neurologic deficit that does not resolve within 24 hours. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI | This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter. | Time for contrast to reach a standardized distal coronary landmark in the culprit vessel | 
| Percentage ST-segment Resolution Prior to PCI | The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI. | Before primary PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, ACS