E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Up to 60 patients with stable angina pectoris and planned PCI at the University Clinic of Jena are randomly assigned to the glycoprotein IIb/IIIa receptor antagonist abciximab or placebo. Randomisation takes place after the diagnostic procedure with knowledge of the coronary anatomy. Patients are planned to undergo balloon dilatation with or without implantation of a bare metal stent for a single vessel stenosis. All will undergo periprocedural Doppler analysis. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065608 |
E.1.2 | Term | Percutaneous coronary intervention |
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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 |
Firstly, we investigate whether in patients with stable angina pectoris receiving a stent the incidence of microembolism is lower in patients who are treated with the glycoprotein IIb/IIIa receptor antagonist abciximab compared to patients who are treated with placebo (testing for superiority). |
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E.2.2 | Secondary objectives of the trial |
Secondly, we want to know whether the incidence of microembolism is directly related to changes in CFVR or elevation of cardiac biomarkers after PCI. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- stable angina pectoris - age between 18 and 80 years - written informed consent |
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E.4 | Principal exclusion criteria |
- elevation of cardiac biomarkers before PCI - left bundle branch block - terminal renal insufficiency - hypothyroidism - skeletal muscle injury - occluded target artery - bifurcation lesion - in-stent restenosis - multivessel intervention - occlusion of side branche(s) - prolonged vasospasm - contraindication for use of abciximab |
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E.5 End points |
E.5.1 | Primary end point(s) |
Total number of HITS (in the time window specified below) in patients where a stent is deployed. The measurement of HITS for each patient is divided into 2 periods: (1) predilation and (2) stent deployment. Trigger points for the collection periods are balloon deflations during resulting appearance of the Doppler flow curves. HITS are counted within 60 seconds immediately after balloon deflations. Only bare stents will be used in this study. Postprocedural CFVR and cardiac biomarkers are monitored for 36 hours after PCI in both groups. |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |