None listed
Conditions
Interventions
Group 1 Type of group
Placebo orally for 24 weeks
Group name:Group 9 Type of group
120 mg of TAK-442 BID for 24 weeks
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: • 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 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).
Exclusion criteria
Exclusion criteria: • The patient is 80 years old. • The patient has a low body weight ( 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The diagnosis of fatal MI or fatal stroke is based on the following: death occurred within 28 days after the onset of acute MI or stroke in the absence of another clear cause, or death occurred more than 28 days after the onset of acute MI or stroke, which according to the best clinical criteria and / or CEC it was determined to cause MI or stroke, as appropriate, or confirmation by autopsy of an acute MI or stroke as a cause of death. Measure:The first occurrence of any myocardial infarction, any stroke, cardiovascular death Timepoints:During and after the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Based on the Definitions of the American College of Cardiology (ACC) to measure results. Measure:The first occurrence of any myocardial infarction Timepoints:During and after the study ; Outcome name:Defined as an acute neurological vascular event with focal signs that last more than 24 hours with or without evidence of primary intracranial hemorrhage (PICH). Cerebrovascular accidents will also be classified as ischemic, hemorrhagic or of uncertain type. Measure:The first occurrence of any stroke Timepoints:During and after the study ; Outcome name:Death occurred in the 28 days following the onset of acute MI or stroke in the absence of another clear cause, or death occurred more than 28 days after the onset of acute MI or stroke, which according to the best clinical criteria and / or CEC it was determined to cause MI or stroke, as appropriate, or confirmation by autopsy of an acute MI or stroke as a cause of death. Measure:The first occurrence of cardiovascular death Timepoints:Durng and after treatment ; Outcome name:For any of the following: unstable angina, transient ischemic attack, heart rhythm disorder, congestive heart failure, syncope or urgent revascularization procedure. Measure:Hospitalization due to cardiovascular causes Timepoints:During and after treatment | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Estonia, Germany, Hungary, India, Korea South, Netherlands, Peru, Romania, Russian Federation, Serbia, South Africa, United Kindgdom, United States
Outcome results
None listed