E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute myocardial infarction with ST elevation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000891 |
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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 |
To evaluate the safety and effect on myocardial function of various doses of KAI-9803 For Injection when administered by intra coronary injection during primary PCI (percutaneous intervention) for acute ST-elevation myocardial infarction (STEMI). |
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E.2.2 | Secondary objectives of the trial |
The effect of KAI-9803 on multiple biomarkers that reflect myocardial viability and myocardial tissue perfusion will be assessed both as a measure of safety and to evaluate potential efficacy endpoints for a future approval-directed clinical trial. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients must:- - have experienced symptoms of cardiac ischemia at rest or with increasing frequency (angina or anginal equivalent) , with episodes lasting for at least 30 minutes within 6 hours of presentation - have persistent segment elevation of more than 0.2mV in at least 2 contiguous precordial leads indicative of anterior MI location (Leads V1-V4) - be not less than 18 years old - have complete occlusion of the left anterior descending artery (TIMI 0-1 flow) demonstrated on the initial angiogram - other criteria in the protocol |
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E.4 | Principal exclusion criteria |
Patients must be excluded for:- - any left bundle branch block (new or old), intraventricular conduction defect, or paced rhythm that would obscure the diagnosis of acute anterior STEMI - any prior documented MI including old Q waves documented on prior ECGs or a clinical history of definite MI - any prior coronary artery bypass grafting - cardiogenic shock at initial presentation, consisting of persistent hypotension (systolic blood pressure < 90 mm Hg for > 20 minutes) and signs of end-organ dysfunction (oliguria, alterred mental status, poor peripheral perfusion or lactic acidosis). - known baseline serum creatinine > 2.5 mg/dL without renal dialysis or renal replacement therapy within 30 days before presentation - other criteria in the protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety endpoints, according to the procedures and timeframes in the protocol, include spcific metrics at each of the following:- - hospitalization - 30 day clinical follow up - 6 month clinical follow up This study is not powered to demonstrate efficacy by clinica or surrogate endpoints. A number of surrogate endpoints will be evaluated to determine the effect of KAI-9803 on myocardial tissue perfusion, infarct size and left ventricular function. These surrogate endpoints will be utilized both as a measure of safety and to evaluate potential efficacy endpoints for a future approval-directed clinical trial. - other endpoints in the protocol
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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 | Information not present in EudraCT |
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 trial will occur at the last (6 month) telephone follow-up with the last patient. |
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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 | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |