acute coronary syndromes MedDRA version: 9.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Product Code: TAK-442
Pharmaceutical Form: Tablet
Current Sponsor code: TAK-442
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the place
Sponsors
Takeda Global Research & Development Centre (Europe) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject has been hospitalized for ACS (UA or MI [NSTEMI or STEMI]) 2. The subject is able to initiate study drug if: a) The index event occurred within the past 7 days (the date of initial hospitalization will be utilized for the date on which the index event occurred), and b) The final acute medical or cardiac procedural intervention for the treatment of ACS (eg, glycoprotein IIb/IIIa inhibitor, anticoagulant doses of low-molecular weight or unfractionated heparin, fibrinolytics, PCI etc.) was last administered or performed at least 36 hours before administration of the first dose of study drug (ie, initiation of study drug must not occur earlier than 36 hours after discontinuation of the last medical or cardiac procedural intervention). 3. The subject has at least 1 of the following additional ischemic risk factors: a) Age =65 years. b) Previous MI. c) The index event was an anterior MI. d) Presence of multivessel coronary disease (stenosis =50%). e) Left bundle branch block. f) Left ventricular ejection fraction =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject is 80 years of age. 2. The subject has low body weight (<50 kg). 3. The subject has severe hypertension (systolic blood pressure =180 mm Hg or diastolic blood pressure =110 mm Hg). 4. The subject has a known bleeding/clotting disorder (including hemophilia A or B and Von Willebrand disease). 5. The subject has acute pericarditis. 6. The subject has a history of intracranial or intraocular bleeding. 7. The subject has a history of gastrointestinal bleeding or gastric or duodenal ulceration within 12 months prior to Randomization. 8. The subject has a history of ischemic stroke or transient ischemic attack within 12 months prior to Randomization. 9. The subject has had major surgery, including coronary artery bypass graft (CABG), within 3 months prior to Randomization or subject has undergone non-major laparoscopic surgery or non-major minimally invasive surgery, within 2 weeks prior to Randomization. 10. The subject has a history of cancer that has not been in remission for at least 5 years. (This criterion does not include those subjects with basal cell or stage I squamous cell carcinoma of the skin.) 11. The subject has a condition for which long-term anticoagulation therapy is indicated (ie, atrial fibrillation, mechanical prosthetic heart valve, or left ventricular thrombus) or requires ongoing use of other excluded medications (see Excluded Medications section). 12. The subject has severe renal dysfunction (calculated creatinine clearance <30 mL/min/1.73 m2). 13. The subject has anemia (ie, hemoglobin <10 g/dL) or thrombocytopenia (ie, platelet count <100x103/µL) that has not resolved prior to Randomization. 14. The subject has alanine aminotransferase (ALT) or total bilirubin levels (except documented Gilbert’s disease) greater than 2 times the upper limit of normal (ULN), active liver disease (including hepatitis C), or jaundice that has not resolved prior to Randomization. 15. The subject has a history of illicit drug use or excessive alcohol intake within 2 years prior to Randomization. 16. If female, the subject is pregnant or lactating. 17. The subject has any other serious disease or condition that would compromise subject safety, increase the risk of bleeding, or make it difficult to successfully manage and follow the subject according to the protocol. 18. The subject has received TAK-442 in a previous clinical study or as a therapeutic agent. 19. The subject has a history of hypersensitivity or allergies to other fXa inhibitors. 20. The subject has received any investigational compound within 30 days prior to Screening (for drugs with a long half-life, within a period of less than 5 times the drug’s half life) or is currently participating in another study which entails the administration of an investigational or marketed drug, supplement or intervention including, but not limited to diet, exercise, lifestyle or invasive procedure. 21. The subject is a study site employee or is an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee involved in conduct of this study. 22. The subject is unable to provide informed consent or is unwilling or unable to understand or comply with the protocol or scheduled appointments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effect of TAK-442 on the incidence of major bleeding when added to standard treatment for prevention of recurrent ischemic events in subjects with recent ACS (including UA, STEMI, or NSTEMI).;Secondary Objective: The secondary objectives of this study are to evaluate the effect of TAK-442 on CV outcomes, effect of TAK-442 on the incidence of other bleeding event categories, the general safety and tolerability of TAK-442, the anticoagulant and antithrombotic effects of TAK-442 as determined by monitoring pharmacodynamic variables and markers of coagulation , and population pharmacokinetics of TAK-442 and metabolites (M-I and M-II).;Primary end point(s): The primary endpoint is the incidence of major bleeding events as defined by the thrombolysis in myocardial infarction (TIMI) scale. The secondary endpoints include: • Composite of CV death, non-fatal MI, non-fatal stroke, or myocardial ischemia requiring hospitalization. • The individual components of the CV composite endpoint. • All-cause death. • Haemorrhagic death. • The following additional composite endpoints: – CV death, non-fatal MI, or myocardial ischemia requiring hospitalisation. – CV death, non-fatal MI, or non-fatal stroke. • Hospitalisation for heart failure. • Safety measures: – The incidence of minor and minimal bleeding events (TIMI scale). – The incidence of major, clinically significant non-major, and minor bleeding events as defined by the secondary bleeding scale. – AEs, safety laboratory tests, 12-lead ECGs, vital signs, and physical examination findings. | — |
Countries
Belgium, Bulgaria, Estonia, Germany, Hungary, United Kingdom
Outcome results
None listed