E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adjunctive antiplatelet therapy prior to primary percutaneous intervention in patients with ST-Elevation Myocardial Infarction (STEMI) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
Assess the safety and tolerability of PRT060128 when used together with standard treatments for STEMI subjects undergoing primary PCI |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 24 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial will be last visit of the last subject. Each subject's last visit will be a follow up contact 30-37 days after enrollment. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |