PER-056-08已完成未知
A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes
适应症
试验速览
研究概览
简要总结
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研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30 至 80（—）
入选标准
- •The patient has been hospitalized by an ACS (UA or MI [NSTEMI or STEMI]) as defined in Appendix E.
- •The patient is able to start with the study drug: a) Within 7 days from the index event, and b) Within a range of 48 +/- 12 hours after the discontinuation of acute medical treatment (ie, other anticoagulants, fibrinolytic therapy or glycoprotein IIb / IIIa antagonists) and c) Within 48 +/- 12 hours after completion of PCI (if performed).
- •The patient has at least 1 of the following additional ischemic risk factors: a) Age> 65 years. b) Previous MI. c) The index event was an earlier MI. d) Presence of multiple coronary artery disease (stenosis> 50%). e) Blocking the left branch of the bundle of His. f) Left ventricular ejection fraction <40% at any time during hospitalization due to the index event. g) Class Killip> II at all times during hospitalization for the index event. h) History of symptomatic congestive heart failure (functional class II-IV according to the New York Heart Association). i) Antecedents of an ischemic stroke or transient ischemic attack more than 12 months before Randomization. j) Presence of peripheral arterial occlusive disease. k) Diabetes mellitus that requires medical therapy to maintain glycemic control. l) Habitual smoker (smokes a product with tobacco at least 3 times a day). m) Moderate renal impairment (calculated creatinine clearance> 30 and <50 ml / min / 1.73 m2).
- •The patient or his legal representative signs a written informed consent form before the start of any study procedure.
- •A female patient with the potential to procreate and who is sexually active must agree to use an adequate method of contraception from the time of Selection until 30 days after receiving the last dose of the study drug. Women WITHOUT the potential to procreate are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as at least 2 years since the last regular menstruation).
排除标准
- •The patient is <30 or> 80 years old.
- •The patient has a low body weight (<50 kg).
- •The patient has severe hypertension (systolic blood pressure> 180 mm Hg or diastolic blood pressure> 110 mm Hg).
- •The patient has a known bleeding / clotting disorder (including hemophilia A or B and von Willebrand´s disease).
- •The patient suffers from acute pericarditis.
- •The patient has a history of intracranial or intraocular hemorrhage.
- •The patient has a history of gastrointestinal hemorrhage or gastric or duodenal ulcer within 12 months prior to Randomization.
- •The patient has a history of an ischemic stroke or transient ischemic attack within 12 months prior to Randomization.
- •The patient has undergone major surgery, including a coronary revascularization graft (CABG), within 3 months prior to Randomization.
- •The patient has a history of cancer that has not been in remission for at least 5 years. (This criterion does not include those patients with basal cell carcinoma or cutaneous squamous cell carcinoma in Stage I).
- •The patient has a disease for which a long-term anticoagulation therapy is indicated (ie, atrial fibrillation, mechanical heart valve prosthesis or left ventricular thrombus) or requires at this time the use of other excluded medications (see section Excluded Medications).
- •The patient has severe renal dysfunction (calculated creatinine clearance <30 mL / min / 1.73 m2).
- •The patient has anemia (ie, hemoglobin <10 g / dL) or thrombocytopenia (ie, platelet count <100xl0VpL) that has not resolved before Randomization.
- •The patient has a level of alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN), active liver disease (including hepatitis C) or jaundice that has not been resolved before Randomization.
- •The patient has a history of illicit drug use or excessive alcohol intake within 2 years prior to Randomization.
- •If a woman, the patient is pregnant or breastfeeding.
- •The patient has any other disease or serious condition that could compromise their safety or make difficult the management and successful follow-up of the patient according to the protocol.
- •The patient has received TAK-442 in a previous clinical study or as a therapeutic agent.
- •The patient has a history of hypersensitivity or allergies to other fXa inhibitors.
- •The patient has received a compound under investigation within 30 days prior to the time of selection (for drugs with a long half-life, within a period of less than 5 times the average life of the drug) or is currently participating in another research study.
- •The subject is an employee of the study site or is a direct relative (ie, spouse, parent, child or sibling) of an employee of the study site involved in conducting this study.
- •The patient is unable to provide informed consent or does not want or is unable to understand or comply with the protocol or scheduled appointments.
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