Adjunctive antiplatelet therapy prior to primary percutaneous intervention in patients with ST-Elevation Myocardial Infarction (STEMI) MedDRA version: 9.1 Level: LLT Classification code 10000891 Term: Acute myocardial infarction
Conditions
Interventions
Product Name: PRT060128 Potassium
Product Code: PRT0606128
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: PRT060128
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Portola Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. · The subject is at least 18 years of age and willing to comply with protocol. · If the subject is a woman, she is without reproductive potential (postmenopausal for = 2 years, after hysterectomy, or consistently using a reliable barrier method or an acceptable form of birth control). · The subject or legally acceptable representative is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 of first medical contact for the presenting STEMI event. · New or old left bundle branch block. · Paced cardiac rhythm. · Previous coronary artery bypass grafting. · Ventricular fibrillation or ventricular tachycardia requiring cardioversion or defibrillation. · Advanced 2nd or 3rd degree heart block. · History or symptoms of a congenital or acquired bleeding disorder or vascular malformation. · History of any prior ischemic stroke or intracranial hemorrhage, neoplasm, or arteriovenous malformation. · History of any TIA symptoms within the past 12 months. · Recent facial or head trauma within the last 30 days. · Recent intraocular hemorrhage within the last 30 days. · 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. · Known allergy or contraindication to the components of PRT060128, aspirin, heparin, clopidogrel, glycoprotein IIb/IIIa inhibitors, or to any contrast media. · Received oral anticoagulants (eg, warfarin) within the last 7 days. · Participation in any investigational drug study 30 days prior to enrollment is prohibited. Participation in a device trial prior to enrollment is acceptable. · Any condition which could interfere with or for which the treatment of might interfere with the conduct of the study, or which would, in the opinion of the Investigator, unacceptably increase the risk of the subject's participation in the study. This would include, but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy, or any unexplained blackouts. · Prior participation in ERASE MI study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1: Evaluate safety and tolerability of IV PRT060128 at doses of 10, 20, 40, and 60 mg as an adjunctive antiplatelet therapy before primary PCI in subjects with STEMI Part 2: Evaluate improvement in TIMI frame count on the initial diagnostic angiogram and pre-PCI ST-segment resolution with PRT060128 in subjects with STEMI who are planned to undergo primary PCI, and safety and tolerability of IV PRT060128;Secondary Objective: Assess the safety and tolerability of PRT060128 when used together with standard treatments for STEMI subjects undergoing primary PCI ;Primary end point(s): Efficacy: The primary efficacy endpoint for the Dose Confirmation phase will consist of two components: 1) Percent ST-segment resolution before the first device activation during primary PCI, or 2) Corrected TIMI frame count on the initial diagnostic angiogram before primary PCI. Safety: 1. TIMI major and minor bleeding through hospital discharge 2. GUSTO severe and moderate bleeding through hospital discharge 3. Intracranial hemorrhage through hospital discharge Suspected bleeding and intracranial hemorrhage events through hospital discharge will be reviewed and adjudicated by an independent Clinical Events Committee | — |
Countries
Austria, Germany
Outcome results
None listed