E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stable patients with obstructive coronary heart disease undergoing elective percutaneous coronary stent implantation. |
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E.1.1.1 | Medical condition in easily understood language |
Stable patients with a significant narrowing of at least one coronary vessel and planned implantation of a coronary stent. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011078 |
E.1.2 | Term | Coronary artery disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069038 |
E.1.2 | Term | Bare metal coronary stent placement |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069037 |
E.1.2 | Term | Drug-eluting coronary stent placement |
E.1.2 | System Organ Class | 100000004865 |
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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 |
Randomized comparison of the pharmacodynamic effectiveness of different loading regimes with P2Y12 receptor antagonists given immediately before elective coronary intervention (clopidogrel 600mg, prasugrel 30mg, prasugrel 60mg). Primary endpoint if the proportion of patients with a platelet aggregation of less than 468 AU x min (Multiplate Test, Roche Diagnostics) tested 1 hours after administration of the loading dose.
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E.2.2 | Secondary objectives of the trial |
Evaluation of further platelet function parameters and timepoints. Evaluation of clinical safety endpoints of the different loading regimes with P2Y12 receptor antagonists given immediately before elective coronary intervention (clopidogrel 600mg, prasugrel 30mg, prasugrel 60mg). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Stable patients with obstructive coronary heart disease and planned coronary stent implantation. Pretreatment with aspirin (≥100mg daily or loading dose of 400mg before coronary angiography). Age ≥ 18 years. Written informed consent. |
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E.4 | Principal exclusion criteria |
Acute myocardial infarction Treatment with ticagrelor, prasugrel, fibrinolysis, or GP IIb/IIIa inhibitor within 7 days before enrollment. Contraindication for treatment with aspirin, clopidogrel, or prasugrel (in particular: active bleeding, history of stroke or TIA). Current oral anticoagulation. Severe thrombocytopenia (< 50.000/µl). Known severe disorder of the coagulation system. Pregnancy or lactation. Dementia. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with ADP-induced platelet function less than 468 AU x min (Multiplate Test, Roche Diagnostics). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 hour after administration of loading dose. Additional analyses for 2 hour and day 1 after administration of loading dose. |
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E.5.2 | Secondary end point(s) |
Evaluation of further platelet function parameters and timepoints. Incidence of ischemic (deat, non-fatal myocardial infarction, urgent coronary revascularization, stroke) and bleeding endpoints (BARC criteria). Impact of genetic and clinical variables on the pharmacodynamic response to different loading regimes. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Bleeding: up to 7 days following enrollment. Ischemic endpoints: up to 30 days following enrollment. Pharmacodynamic response: 0, 0.5, 1.0, 1.5, 2.0, 3.0 hours and day 1 after loading dose. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
blinded endpoints (pharmacodynamic assessment) |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | No |
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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LVLS (visit of the last subject) |
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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 |