Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes
A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes
2 other identifiers
interventional
2,753
19 countries
103
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2008
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 9, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedApril 13, 2016
March 1, 2016
2.3 years
May 9, 2008
March 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Major Bleeding Events defined by the Thrombolysis in Myocardial Infarction Scale.
On Occurrence (Up to 24 weeks)
Secondary Outcomes (13)
Composite of Cardiovascular Mortality, non-fatal Myocardial Infarction, non-fatal Stroke, or Myocardial Ischemia requiring hospitalization.
Week 24
Cardiovascular Mortality.
Week 24.
Non-fatal Myocardial Infarction.
Week 24.
Non-fatal Stroke.
Week 24.
Myocardial Ischemia requiring hospitalization.
Week 24.
- +8 more secondary outcomes
Study Arms (9)
TAK-442 10 mg BID
EXPERIMENTALAdded with standard care for recurrent ischemic events.
TAK-442 20 mg BID
EXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 40 mg QD
EXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 40 mg BID
EXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 80 mg QD
EXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 80 mg BID
EXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 160 mg QD
EXPERIMENTALAdded with standard care for recurrent ischemic events
TAK-442 120 mg BID
EXPERIMENTALAdded with standard care for recurrent ischemic events
Placebo
PLACEBO COMPARATORAdded with standard care for recurrent ischemic events
Interventions
Stage I: TAK-442 10 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.
Eligibility Criteria
You may qualify if:
- Has been hospitalized for acute coronary syndrome
- Is able to initiate study drug if:
- 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
- The final acute medical or cardiac procedural intervention for the treatment of acute coronary syndrome was last administered or performed at least 36 hours before administration of the first dose of study drug.
- Has at least 1 of the following additional ischemic risk factors:
- Previous myocardial infarction.
- The index event was an anterior myocardial infarction.
- Presence of multivessel coronary disease
- Left bundle branch block.
- Left ventricular ejection fraction less than 40% at any time during hospitalization for the index event.
- Killip class greater than or equal to II at any time during hospitalization for the index event.
- History of symptomatic congestive heart failure
- History of ischemic stroke or transient ischemic attack.
- Presence of peripheral arterial obstructive disease.
- Diabetes mellitus requiring medical therapy to maintain glycemic control.
- +3 more criteria
You may not qualify if:
- Has low body weight greater than 50 kg.
- Has severe hypertension.
- Has a known bleeding/clotting disorder.
- Has acute pericarditis.
- Has a history of intracranial or intraocular bleeding.
- Has a history of gastrointestinal bleeding or gastric or duodenal ulceration.
- Has a history of ischemic stroke or transient ischemic attack.
- Has had major surgery, including coronary artery bypass graft or has undergone non-major laparoscopic surgery or non-major minimally invasive surgery, within 2 weeks prior to Randomization.
- Has a history of cancer that has not been in remission for at least 5 years.
- Has a condition for which long-term anticoagulation therapy is indicated or requires ongoing use of other excluded medications.
- Has severe renal dysfunction.
- Has anemia or thrombocytopenia that has not resolved prior to Randomization.
- Has alanine aminotransferase or total bilirubin levels greater than 2 times the upper limit of normal, active liver disease or jaundice.
- Has a history of illicit drug use or excessive alcohol intake.
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (103)
Unknown Facility
Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Pensecola, Florida, United States
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West Des Moines, Iowa, United States
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Salisbury, Maryland, United States
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Minneapolis, Minnesota, United States
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Cherry Hill, New Jersey, United States
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Toledo, Ohio, United States
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Sayre, Pennsylvania, United States
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Houston, Texas, United States
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Victoria, Texas, United States
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Layton, Utah, United States
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Roanoke, Virginia, United States
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Buenos Aires, Argentina
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Bonheiden, Belgium
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Genk, Belgium
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Liège, Belgium
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Porto Algere, Brazil
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Recife, Brazil
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Haskovo, Bulgaria
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Pazardzhik, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Silistra, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Greater Sudbury, Ontario, Canada
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Toronto, Ontario, Canada
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Chilliwack, Canada
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Saint-Charles-Borromée, Canada
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Vancouver, Canada
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Santiago, Chile
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Temuco, Chile
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Tallinn, Estonia
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Bad Nauheim, Germany
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Langen, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Nyíregyháza, Hungary
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Szeged, Hungary
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Székesfehérvár, Hungary
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Szolnok, Hungary
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Zalaegerszeg, Hungary
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Ahmedabad, India
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Bikaner, India
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Calicut, India
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Indore, India
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Jaipur, India
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Mangaluru, India
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Mumbai, India
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Nagpur, India
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New Delhi, India
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Pune, India
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Shimoga, India
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Thrissur, India
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Trivandrum, India
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Vadodara, India
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Amsterdam, Netherlands
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Hardenberg, Netherlands
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Hoorn, Netherlands
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The Hague, Netherlands
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Tilburg, Netherlands
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Arequipa, Peru
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Lima, Peru
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Bacau, Romania
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Baia Mare, Romania
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Brasov, Romania
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Brăila, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Suceava, Romania
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Târgovişte, Romania
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Barnaul, Russia
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Kemerovo, Russia
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Krasnoyarsk, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Tomsk, Russia
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Tyumen, Russia
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Voronezh, Russia
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Yaroslavl, Russia
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Kamenica, Serbia
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Sremska, Serbia
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Bloemfontein, South Africa
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CapeTown, South Africa
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Goodwood, South Africa
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Johannesburg, South Africa
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Parow, South Africa
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Pinelands, South Africa
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Pretoria, South Africa
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Randburg, South Africa
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Busan, South Korea
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Daegu, South Korea
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Jeonrabukdo, South Korea
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Seoul, South Korea
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Airdrie, North Lanarkshire, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Executive Medical Director Clinical Science
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2008
First Posted
May 13, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
April 13, 2016
Record last verified: 2016-03