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Клинические исследования в Украине

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Описание
Краткое названиеAn Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
Полное названиеA Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
СпонсорJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industry
ИсточникJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Под контролемUnited States: Food and Drug Administration
Краткое описаниеThe purpose of this study is to determine whether rivaroxaban in addition to standard care
reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke
in patients with a recent acute coronary syndrome compared with placebo.
СостояниеИдет набор
Дата началаNovember 2008
ФазаPhase 3
Подробное описаниеAcute coronary syndrome (ACS) is a serious and life threatening condition. Following an
acute coronary syndrome event patients are at risk of important additional clinical events
such as death, myocardial infarction, and stroke. Six months after patients present with an
index event of ST-segment myocardial infarction, approximately 15% will either have died or
had another episode of myocardial ischemia, and a similar situation exists for
non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized;
double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban
in addition to standard care in patients with a recent ACS. Patients will be given
rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to
standard care.
Вид исследованияAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Patients must be currently receiving aspirin therapy alone or in combination with a
thienopyridine per national or local dosing recommendation

- Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted
at least 10 minutes at rest and occurred 48 hours or less before going to the
hospital

Exclusion Criteria:

- Any condition that, in the opinion of the investigator, contraindicates anticoagulant
therapy or would have an unacceptable risk of bleeding

- Need for continued anticoagulant therapy

- Significant renal impairment or known significant liver disease
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеAcute Coronary Syndrome
Применяемое лечение
DrugRivaroxaban 2.5 mg
DrugRivaroxaban 5 mg
DrugPlacebo
Контакты и расположение
Cherkassy
Chernovtsy
Dnepropetrovsk
Donetsk
Ivano-Frankivsk
Kharkov
Khemelnitskiy
Kiev
Kiev
Lugansk
Lutsk
Lviv
Nikolaev
Poltava
Sumy
Ternopol
Uzhgorod
Vinnitsa
Zaporozhye
Zhytomir
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