A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes
- Conditions
- acute coronary syndromesMedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome
- Registration Number
- EUCTR2008-000091-24-BG
- Lead Sponsor
- Takeda Global Research & Development Centre (Europe) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2750
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 <40% at any time during hospitalization for the index event.
g) Killip class =II at any time during hospitalization for the index event.
h) History of symptomatic congestive heart failure (New York Heart Association functional class II-IV).
i) History of ischemic stroke or transient ischemic attack more than 12 months prior to Randomization.
j) Presence of peripheral arterial obstructive disease.
k) Diabetes mellitus requiring medical therapy to maintain glycemic control.
l) Current smoker (smokes a tobacco product at least 3 times daily).
m) Moderate renal impairment (calculated creatinine clearance =30 and <50 ml/min/1.73 m2).
4. The subject signs a written informed consent form prior to the initiation of any study procedures.
5. A female subject of childbearing potential who is sexually active must agree to use adequate contraception from Screening until 30 days after receiving the last dose of study drug. Women NOT of child bearing potential 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 last regular menses).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. The subject is <30 or >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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method