E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with coronary atheroschlerosis who require PCI |
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E.1.1.1 | Medical condition in easily understood language |
Patients with blocked blood vessels who have to have a balloon procedure known as a PCI to open the blocked vessels |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011076 |
E.1.2 | Term | Coronary artery atherosclerosis |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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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 in patients requiring percutaneous coronary intervention (PCI), cangrelor provides superior efficacy to clopidogrel standard of care, as measured by a composite of all cause mortality, myocardial infarction (MI), ischemia-driven revascularization (IDR) and stent thrombosis. |
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E.2.2 | Secondary objectives of the trial |
The main safety objective is to demonstrate that cangrelor has an acceptable safety profile without excessive periprocedural bleeding as measured by Thrombolysis in Myocardial Infarction (TIMI) scale compared to standard of care.
The value objective is to demonstrate that a lower use of healthcare resources is required to overcome limitations of irreversible platelet inhibition..
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or non-pregnant female at least 18 years of age
2. Patients undergoing PCI:
a. Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis
b. Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
c. STEMI patients (diagnostic angiography not required)
3. Provide written informed consent
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E.4 | Principal exclusion criteria |
1. Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
2. Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
3. Abciximab usage within 7 days preceding randomization
4. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
5. 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
6. Impaired hemostasis: known international normalized ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand’s disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders); thrombocytopenia (platelet count <100,000/µL), or history of thrombocytopenia or neutropenia associated with clopidogrel
7. 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)
8. Admission planned for <12 hours following PCI
9. Planned staged PCI procedure where the second stage will occur ≤30 days after the first intervention
10. Inability to give informed consent or comply with study related procedures, or high likelihood of being unavailable for follow-up
11. Known or suspected pregnancy, or lactating females
12. Allergy, hypersensitivity, or contraindication to aspirin, clopidogrel, cangrelor, mannitol, sorbitol, or microcrystalline cellulose
13. Active treatment with other investigational agents or devices at the time of randomization or planned use during the 30 day follow-up period
14. Previous enrollment in this trial
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the composite incidence of all cause mortality, MI, IDR and stent thrombosis within the 48 hours after randomization. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
48 hrs after randomization |
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E.5.2 | Secondary end point(s) |
Incidence of stent thrombosis at 48 hours post randomization |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
48 hrs 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 | 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 | 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) | 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 | No |
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 | 2 |
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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 57 |
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 | No |
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 |
Brazil |
Georgia |
India |
Korea, Republic of |
New Zealand |
Russian Federation |
Thailand |
United States |
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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 | 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 |