| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Treatment of Acute Coronay Syndrome in medically managed subjects enrolled within 7 days of the UA/NSTEMI index event |
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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 | 10051592 |
| E.1.2 | Term | Acute coronary syndrome |
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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 test the hypothesis that prasugrel and aspirin is superior to clopidogrel and aspirin in the treatment of medically managed subjects enrolled within 7 days of the unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) index event. Superiority will be assessed by the reduction in risk of the composite endpoint of first occurrence of cardiovascular (CV) death, myocardial infarction (MI), or stroke throughout the study. The primary analysis will be conducted in a hierarchical manner, with evaluation of the primary endpoint performed first in medically managed UA/NSTEMI subjects <75 years of age. Conditional on successfully establishing superiority in the primary analysis, the same composite endpoint will be evaluated in the entire population. |
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| E.2.2 | Secondary objectives of the trial |
| The following secondary endpoints will be analyzed in both the population of medically managed UA/NSTEMI subjects age < 75 years and the entire medically managed UA/NSTEMI population (subjects < age 75 years and subjects ≥ age 75 years). The secondary efficacy objectives are to compare the prasugrel and clopidogrel groups with respect to: The risk of the composite endpoint of first occurrence of CV death and MI. The risk of the composite endpoint of first occurrence of CV death, MI, stroke, or rehospitalization for recurrent UA. The risk of the composite endpoint of first occurrence of all cause death, MI, or stroke. Safety objectives include the comparison of prasugrel with clopidogrel with respect to non-CABG related bleeding events classified according to the TIMI criteria and GUSTO definitions and overall safety and tolerability based on vital signs, laboratory values, and treatment-emergent adverse events |
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| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOECONOMIA: Versione:a Data:2008/02/06 Titolo:Sottostudio su gli esiti sanitari Obiettivi:Si procedera', per tutta la durata della ricerca, a una stima dei costi sanitari cumulativi facendo uso di informazioni inerenti alla fatturazione ospedaliera. La qualita' di vita sara' misurata nei soggetti al basale mediante il questionario EQ-5D e altre misure selezionate. Da un campione casuale di soggetti saranno raccolti dati di follow-up sulla qualita' di vita.
ALTRI SOTTOSTUDI: 1) sottostudio sulla funzionalita' piastrinica (non tutti i centri vi partecipano. Fa parte del protocollo principale datato 6-feb-08. 2) prelievo e conservazione di campioni di DNA in una banca
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| E.3 | Principal inclusion criteria |
| - Male or female, 18 years of age or older who have had a UA/NSTEMI index event within 7 days (168hours) prior to randomization. - Have had a decision for medical management (that is, neither percutaneous coronary intervention [PCI] nor coronary artery bypass graft [CABG] is planned for management of the index event). This decision should be made with reasonable certainty and be based on angiography and/or the subject’s known clinical information (may include, but need not be limited to known coronary anatomy, age, or co-morbidity). For subjects whose medical management decision and randomization occurs no later than 24 hours following onset of the index event, prior clopidogrel treatment is not a consideration for eligibility. For subjects with a medical management decision who are randomized beyond 24 hours of onset of the index event, commercial clopidogrel must have been received according to standard of care practice guidelines no later than 24 hours following the onset of the index event . - Have had at least 1 of the following 3 high-risk features at the time of the UA/NSTEMI event: Age >60 years Prior MI evidenced by pre-existing Q waves, or demonstration of infarction on imaging studies, or prior documentation of elevated cardiac markers. Diabetes Mellitus - defined by concomitant treatment with an oral hypoglycemic agent and/or insulin. - Have at least 1 native coronary artery stenosis > 50% (applies only to those subjects who undergo diagnostic coronary angiography within 7 days of the onset of the index event but do not undergo PCI or CABG after angiography is performed |
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| E.4 | Principal exclusion criteria |
Cardiovascular Exclusion Criteria
[5] Decision for medical management >24 hours after the onset of the
index event without commercial clopidogrel treatment within 24 hours
following the onset of the index event (Note: commercial clopidogrel
treatment must continue daily thereafter until randomization).
[6] Previous or planned (during the index hospitalization or thereafter)
PCI or CABG as treatment for the index event.
[7] PCI or CABG within the previous 30 days.
[8] STEMI as the index event.
[9] Cardiogenic shock within the previous 24 hours (defined as a systolic
blood pressure <90 mm Hg associated with clinical evidence of endorgan
hypoperfusion, or hypotension requiring vasopressors to
maintain systolic blood pressure over 90 mm Hg and associated with
clinical evidence of end-organ hypoperfusion).
[10] Refractory ventricular arrhythmias within the previous 24 hours.
[11] Symptoms of New York Heart Association (NYHA) Class IV
congestive heart failure (CHF) within the previous 24 hours (see
Attachment TABY.4 for NYHA CHF classifications).
Exclusion Criteria Related to Bleeding
[12] Contraindicated for antiplatelet therapy.
[13] Received fibrinolytic therapy as initial treatment for the index event.
[14] Any history of bleeding diathesis.
[15] Clinical findings associated, in the judgment of the investigator, with
an unacceptably high risk of bleeding.
[16] Any of the following:
History of ischemic or hemorrhagic stroke
Intracranial neoplasm, arteriovenous malformation, or aneurysm
History of any TIA symptoms.
[17] International Normalized Ratio (INR) known to be >1.5 at the time of
screening.
[18] Platelet count of <100,000/mm3 at the time of screening.
[19] Anemia (hemoglobin [Hgb] <10 gm/dL) at the time of screening.
[20] History of spontaneous gastrointestinal bleeding requiring in-hospital
treatment.
[21] History of spontaneous non-gastrointestinal internal bleeding requiring
in-hospital treatment.
[22] Currently receiving hemodialysis or peritoneal dialysis.
Prior/Concomitant Therapy Exclusion Criteria
[23] History of intolerance or allergy to aspirin or approved thienopyridines
(ticlopidine or clopidogrel).
[24] Treated with ticlopidine within 5 days of randomization.
[25] Receiving prasugrel treatment at the time of screening.
[26] Receiving oral anticoagulants at the time of screening or are
anticipated to require oral anticoagulants therapy during the course of
the study.
[27] Receiving daily treatment with nonsteroidal anti-inflammatory drugs
(NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be
discontinued or are anticipated to require >2 weeks of daily treatment
with NSAIDs or COX2 inhibitors during the study.
General Exclusion Criteria
[28] Unwilling to provide or not sufficiently mentally competent to provide
written informed consent.
[29] Study site personnel directly affiliated with the study or are immediate
family of study site personnel directly affiliated with the study.
Immediate family is defined as a spouse, parent, child, or sibling,
whether biological or legally adopted.
[30] Employed by Eli Lilly and Company, Ube Industries Limited, Daiichi
Sankyo Pharma Inc, the academic research organization (ARO), or the
contract research organization (CRO) (that is, employees, temporary
contract workers, or designees responsible for the conduct of the
study). |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary efficacy endpoint is the time to the first occurrence of the composite of CV death, MI, or stroke. |
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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 | No |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | Yes |
| 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 | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| 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
| 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 | 30 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 250 |
| 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 |
|
| 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
|
| Visita dell'ultimo paziente |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 3 |
| 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 | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
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