E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with coronary atherosclerosis who require PCI (with or without stent). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011076 |
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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 |
The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality, myocardial infarction (MI), and ischemia-driven revascularization (IDR). |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints: ユ Incidence of : - all-cause mortality and MI at 48 hours - all-cause mortality and MI at 30 days - all-cause mortality, MI and IDR at 30 days ユ Individual incidence of components of the composite (all-cause mortality, MI, and IDR) at 48 hours and 30 days ユ Incidence of stroke, distinguished by type, at 48 hours ユ Incidence of abrupt closure, threatened abrupt closure, need for urgent coronary artery bypass graft (CABG) surgery, or unsuccessful procedure during the index PCI ユ Incidence of all-cause mortality at 6 months (ascertained at the 1 year follow-up) and 1 year |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male or non-pregnant female at least 18 years of age 2. Diagnostic coronary angiography demonstrating atherosclerosis amenable to treatment by PCI with or without stent implantation 3. Provide written informed consent before initiation of any study-related procedure Importantly, the treating physician must have knowledge of the coronary anatomy and suitability for PCI prior to randomization, except for patients diagnosed with STEMI. Due to the compelling nature of STEMI and the high likelihood of a percutaneous intervention, these subjects may be randomized on diagnosis, preferably in the emergency department, provided there is no impediment to primary PCI. |
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E.4 | Principal exclusion criteria |
1 . Planned staged PCI procedure where the second stage will occur <= 30 days after the first intervention 2 Admission planned for <12 hrs following PCI 3 Known or suspected pregnancy, or lactating females 4. Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); currently receiving warfarin, active bleeding 5. Impaired hemostasis: known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrandメs disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/ᄉL), or history of thrombocytopenia or neutropenia associated with clopidogrel 6. Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization (systolic blood pressure>180 mm Hg or diastolic blood pressure> 110 mm Hg) 7. Receipt of fibrinolytic therapy in the 12 hours preceding randomization 8. Receipt of a clopidogrel dose exceeding the maintenance dose (ie, >75 mg) at any time in the 5 days preceding randomization (subjects receiving chronic clopidogrel therapy at a dose of 75 mg are eligible) 9. Not a candidate for PCI 10. Inability to swallow study capsules 11. Allergy, hypersensitivity, or contraindication to clopidogrel, cangrelor, mannitol, sorbitol, or microcrystalline cellulose 12. Treatment with other investigational agents or devices within the 30 days preceding randomization, planned use of investigational drugs or devices, or previous enrollment in this trial 13. Known alcohol or illicit substance abuse 14. Inability to give informed consent or high likelihood of being unavailable for follow-up |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is a composite incidence of all-cause mortality, MI, and IDR assessed 48 hours after randomization. |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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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.8.3 |
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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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 | 0 |
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 | 0 |