E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Thrombotic events associated with percutaneous coronary intervention (PCI) in patients with unstable angina or Non ST-Segment Elevation Myocardial Infarction (NSTEMI), or stable angina with at least 2 factors indicating a high risk PCI. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011076 |
E.1.2 | Term | Coronary artery atherosclerosis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011078 |
E.1.2 | Term | Coronary artery disease |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013210 |
E.1.2 | Term | Disorder coronary artery |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063933 |
E.1.2 | Term | Coronary stent thrombosis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065608 |
E.1.2 | Term | Percutaneous coronary intervention |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003211 |
E.1.2 | Term | Arteriosclerosis coronary artery |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011067 |
E.1.2 | Term | Coronary angiogram abnormal |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011093 |
E.1.2 | Term | Coronary atherosclerosis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011099 |
E.1.2 | Term | Coronary disease |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011076 |
E.1.2 | Term | Coronary artery atherosclerosis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011093 |
E.1.2 | Term | Coronary atherosclerosis |
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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 |
To compare the safety of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients. |
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E.2.2 | Secondary objectives of the trial |
To compare the tolerability, biological and clinical effectiveness of ALX 0081 versus ReoPro® in high risk PCI patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Have unstable angina or NSTEMI, or stable angina with at least 2 factors indicating a high risk PCI as follows: - patient related: diabetic patients, renal failure (glomerular filtration rate < 60), reduced left ventricular ejection fraction < 35%, age > 75 years, female gender and/or - lesion/anatomy related: SYNTAX score > 26, bifurcation lesions, multi-vessel disease, intracoronary thrombus. 2. Adequate hematological function including platelets > 100000/mm3. 3. Body mass index (BMI) ≥18 kg/m2 and ≤ 35 kg/m2. 4. Aged ≥ 18 years old. 5. Women of childbearing potential must be practicing a medically acceptable contraceptive regimen. Only males who do not want to father children during the study and in the first 4 months after treatment may be included in the study. During this period, safe contraception is mandatory. Male patients who are sexually active must use a condom during intercourse and ensure that the female partner uses a reliable contraceptive method, or they must refrain from sexual intercourse during the entire clinical study. As reliable contraceptive methods for female partners the following measures are accepted: • Hormonal contraception (e.g. pill, depot injection) • Intrauterine device • Diaphragm with spermicide 6. Patients must be accessible for follow-up. 7. Has a sufficient command to read and understand all instructions necessary for giving informed consent and participating in the study. 8. Has signed and dated written informed consent prior to any study-related procedures.
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E.4 | Principal exclusion criteria |
1. Previous (within 30 days) treatment with GPIIb/IIIa inhibitors (such as ReoPro®). 2. ST-elevation myocardial infarction (STEMI). 3. Chronic total occlusion of a coronary artery. 4. Scheduled rotablator procedure. 5. PCI of the arterial or venous by-pass graft. 6. Any contra-indication for ReoPro®. 7. Major organ dysfunction, infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment. 8. Known hypersensitivity to human/humanized antibodies. 9. Women who are pregnant or lactating. 10. Dementia or significantly altered mental status that would prohibit understanding the study procedures and giving informed consent. 11. Use of vitamin K antagonists and/or Factor Xa inhibitors within 4 weeks prior to admission to the Hospital Intensive Care Unit. 12. Use of GPIIa/IIIb inhibitors other then ReoPro®, prasugrel, bivalirudin and fondaparinux prior to and throughout the study. 13. Known history of acquired or congenital bleeding disorder, coagulopathy or platelet disorder. 14. Evidence of active pathological bleeding at screening or history of clinically significant bleeding (such as gastrointestinal or genitourinary) within the last 6 months prior to screening visit, unless the cause has been definitely corrected 15. History of intracranial bleeding e.g. hemorrhagic stroke, subdural hematoma, subarachnoid hemorrhage) or history of hemorrhagic retinopathy. 16. History of ischemic stroke or TIA, within the past year prior to screening or known structural cerebral vascular lesion (e.g. arteriovenous malformation, aneurysm). 17. History of New York Heart Association class III or IV congestive heart failure or history of severe, uncontrolled cardiac arrhythmias at screening. 18. Indication for further diagnostic testing prior to decision to perform PCI, planned elective surgical operation or major invasive procedures or traumas from 30 days prior to screening to completion of the study at Day 30 (the decision of what constitutes a major invasive procedure or trauma will be at the discretion of the investigator in conjunction with review and approval by the Medical Monitor). 19. Use of another investigational drug or device within previous 30 days (12 weeks for investigational devices, e.g. unapproved stents) prior to screening.
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety: Incidence and severity of bleeding classified by the following criteria within 30 days: - TIMI Major bleeding events - TIMI Minor bleeding events - Bleeding events requiring medical attention, defined as TIMI minimal bleeding events.
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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.8.2.3.1 | Comparator description |
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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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 44 |
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 | 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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The study will end when the last patient completes the 1-year follow-up visit. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |