Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and tolerability of multiple doses of
      TAK-442once daily, (QD) or twice daily (BID), in subjects with acute coronary syndrome
      (unstable angina, myocardial infarction).
    

Detailed description: 
      Acute coronary syndrome, including myocardial infarction with or without ST-segment elevation
      and stable or unstable angina, is acknowledged to represent collectively a major global
      healthcare problem. Despite existing treatments, the rates of patient mortality, myocardial
      infarction and hospital readmissions during follow-up remain very high.

      Due to its critical role in propagating the blood coagulation cascade, activated factor X now
      is considered to be a major therapeutic target in the development of novel antithrombotic
      therapy by blocking thrombin generation and attenuating the formation of fibrin. Therefore,
      activated factor X inhibitors, exhibiting either indirect or direct modes of action, are
      among the novel agents under investigation in the treatment of acute coronary syndrome.

      This study will evaluate the safety and tolerability of TAK-442 compared with placebo in
      post-acute coronary syndrome subjects who are also receiving standard antiplatelet and other
      cardiovascular therapy.

      Individuals who want to participate in this study will be required to provide written
      informed consent. Study participation is anticipated to be approximately 3.5 months. Multiple
      procedures will occur at each visit which may include fasting, blood collection, urine
      collection, physical examinations, electrocardiograms and bilateral venogram.
    

Intervention name(s): TAK-442; TAK-442; TAK-442; TAK-442; TAK-442; TAK-442; TAK-442; TAK-442; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Stage I: TAK-442 10 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.; Stage I: TAK-442 20 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.; Stage I: TAK-442 40 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.; Stage II: TAK-442 40 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.; Stage II: TAK-442 80 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.; Stage II: TAK-442 80 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.; Stage III: TAK-442 160 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.; Stage III: TAK-442 120 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.; Stages I, II & III: TAK-442 placebo-matching capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
Intervention MeSH terms: 1-(1-(3-((6-chloronaphthalen-2-yl)sulfonyl)-2-hydroxypropanoyl)piperidin-4-yl)tetrahydropyrimidin-2(1H)-one
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Unstable Angina; Myocardial Infarction; Thrombolysis; Anticoagulant; Acute Coronary Syndrome