E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute coronary syndrome (NSTEMI) due to coronary artery disease |
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MedDRA Classification |
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 |
Myocardial infarction leads to microvascular dysfunction with consecutively reduced coronary flow reserve, which persists after 4 months. Moreover, recent clinical trials have shown that a reduced coronary flow reserve is associated with adverse outcome in the future. Intracoronary infusion of bone marrow-derived progenitor cells lead to complete normalization of coronary blood flow, as demonstrated by the placebo-controlled, double-blind REPAIR-AMI trial, suggesting increased neovascularization by the infused cells . Therefore, the primary objective of the current trial is to improve coronary flow reserve in patients with NSTEMI by intracoronary infusion of autologous bone marrow-derived mononuclear progenitor cells, compared with a placebo group, in a double-blind way. |
|
E.2.2 | Secondary objectives of the trial |
As secondary endpoints the relative coronary flow reserve, vascular resistences and coronary blood flow will be assessed, as well as cardiovascular events like death, myocardial (re-) infarction, coronary revascularization, and hospitalization for heart failure, and quality of life. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-NSTEMI, treated with sussessful percutaneous coronary intervention and stent implantation -hemodynamic stability without intravenous catechoamines or mechanical assist within 6 hours after PCI -age 18 to 80 years -written informed consent |
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E.4 | Principal exclusion criteria |
- STEMI - heart failure (ejection fraction <= 30%) - arteriovenous malformation or aneurysms - active infection, fever, diarrhoea within 4 weeks - chronic inflammatory diseases, HIV infection, active hepatitis - neoplastic disease within 5 years without documented complete remission - stroke within 3 months - reduced renal function (creatinine > = 2,5 mg/dl) - hepatic disease (GOT > 2 xUNL, spontaneous INR > 1,5) - hematological disorders (anaemia (Hb < 8,5 mg/dl), thrombocytopenia (< 100000), - splenomegaly) - known allergies to Clopidogrel, Heparin, Abciximab - bleeding disorders - GI bleeding within 3 months - major surgery or trauma within 2 months - uncontrolled hypertension - pregnancy - mental retardation - participation in other clinical trial within 30 days - previous stem cell therapy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of corornary flow reserve in the infarct artery after 4 months |
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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 | No |
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 | No |
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 | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
|
Primary end-point achieved after 4 months, secondary end points after 12 months, unblinding for data analysis after completion of 4 months follow-up of all patients; after 12 months standard treatement for coronary artery disease in our outpatient clinics |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |