Acute Coronary SyndromePhase 2NCT00677053
Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes
A Phase 2 study testing TAK-442 in people with Acute Coronary Syndrome, run by Takeda at 103 sites in 19 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- TAK-442
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,753 participants
- Where
- 103 sitesin 19 countries
- Study dates
- Mar 2008to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 18Show fewer
- 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.
- Current smoker
- Moderate renal impairment
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
- Has received TAK-442 in a previous clinical study or as a therapeutic agent.
- Has a history of hypersensitivity or allergies to other fXa inhibitors.
- Has received any investigational compound within 30 days prior to Screening 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.
- Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- azole antifungal agents
- cyclosporine
- clarithromycin
- HIV protease inhibitors
- nefazodone
- ritonavir
- quinidine
- amiodarone
- verapamil
Trial locations and contacts
103 sites in 19 countries.
103 sites in 19 countries
United States15 sites
Study site
Birmingham, Alabama
Study site
Cherry Hill, New Jersey
Study site
Houston, Texas
Study site
Layton, Utah
Study site
Minneapolis, Minnesota
Study site
Newark, Delaware
Study site
Pensecola, Florida
Study site
Roanoke, Virginia
Study site
Salisbury, Maryland
Study site
Sayre, Pennsylvania
Study site
Toledo, Ohio
Study site
Tucson, Arizona
Study site
Victoria, Texas
Study site
Washington D.C., District of Columbia
Study site
West Des Moines, Iowa
India14 sites
Study site
Ahmedabad
Study site
Bikaner
Study site
Calicut
Study site
Indore
Study site
Jaipur
Study site
Mangaluru
Study site
Mumbai
Study site
Nagpur
Study site
New Delhi
Study site
Pune
Study site
Shimoga
Study site
Thrissur
Study site
Trivandrum
Study site
Vadodara
Russia12 sites
Study site
Barnaul
Study site
Kemerovo
Study site
Krasnoyarsk
Study site
Moscow
Study site
Novosibirsk
Study site
Saint Petersburg
Study site
Samara
Study site
Saratov
Study site
Tomsk
Study site
Tyumen
Study site
Voronezh
Study site
Yaroslavl
Bulgaria9 sites
Study site
Haskovo
Study site
Pazardzhik
Study site
Pleven
Study site
Plovdiv
Study site
Rousse
Study site
Silistra
Study site
Sofia
Study site
Stara Zagora
Study site
Varna
Romania8 sites
Study site
Bacau
Study site
Baia Mare
Study site
Brăila
Study site
Brasov
Study site
Bucharest
Study site
Cluj-Napoca
Study site
Suceava
Study site
Targoviste
South Africa8 sites
Study site
Bloemfontein
Study site
CapeTown
Study site
Goodwood
Study site
Johannesburg
Study site
Parow
Study site
Pinelands
Study site
Pretoria
Study site
Randburg
Hungary7 sites
Study site
Budapest
Study site
Debrecen
Study site
Nyíregyháza
Study site
Szeged
Study site
Székesfehérvár
Study site
Szolnok
Study site
Zalaegerszeg
Canada5 sites
Study site
Chilliwack
Study site
Greater Sudbury, Ontario
Study site
Saint-Charles-Borromée
Study site
Toronto, Ontario
Study site
Vancouver
Netherlands5 sites
Study site
Amsterdam
Study site
Hardenberg
Study site
Hoorn
Study site
The Hague
Study site
Tilburg
South Korea4 sites
Study site
Busan
Study site
Daegu
Study site
Jeonrabukdo
Study site
Seoul
About this study
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes
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).
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- TAK-442, Placebo
- Keywords
- Unstable Angina, Myocardial Infarction, Thrombolysis, Anticoagulant, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome, Angina, Unstable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-442Drug
Stage I: TAK-442 10 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
TAK-442Drug
Stage I: TAK-442 20 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
TAK-442Drug
Stage I: TAK-442 40 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.
TAK-442Drug
Stage II: TAK-442 40 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
TAK-442Drug
Stage II: TAK-442 80 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.
TAK-442Drug
Stage II: TAK-442 80 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
TAK-442Drug
Stage III: TAK-442 160 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks.
TAK-442Drug
Stage III: TAK-442 120 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
PlaceboDrug
Stages I, II \& III: TAK-442 placebo-matching capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TAK-442 10 mg BID | Experimental | Added with standard care for recurrent ischemic events. Receives: Drug: TAK-442 |
| TAK-442 20 mg BID | Experimental | Added with standard care for recurrent ischemic events Receives: Drug: TAK-442 |
| TAK-442 40 mg QD | Experimental | Added with standard care for recurrent ischemic events Receives: Drug: TAK-442 |
| TAK-442 40 mg BID | Experimental | Added with standard care for recurrent ischemic events Receives: Drug: TAK-442 |
| TAK-442 80 mg QD | Experimental | Added with standard care for recurrent ischemic events Receives: Drug: TAK-442 |
| TAK-442 80 mg BID | Experimental | Added with standard care for recurrent ischemic events Receives: Drug: TAK-442 |
| TAK-442 160 mg QD | Experimental | Added with standard care for recurrent ischemic events Receives: Drug: TAK-442 |
| TAK-442 120 mg BID | Experimental | Added with standard care for recurrent ischemic events Receives: Drug: TAK-442 |
| Placebo | Placebo comparator | Added with standard care for recurrent ischemic events Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Bleeding Events defined by the Thrombolysis in Myocardial Infarction Scale.
Measured: 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.
Measured: Week 24
Cardiovascular Mortality.
Measured: Week 24.
Non-fatal Myocardial Infarction.
Measured: Week 24.
Non-fatal Stroke.
Measured: Week 24.
Myocardial Ischemia requiring hospitalization.
Measured: Week 24.
All-cause Mortality.
Measured: Week 24.
Hemorrhagic Mortality.
Measured: Week 24.
Composite of Cardiovascular death, non-fatal Myocardial Infarction, or Myocardial Ischemia requiring hospitalization.
Measured: Week 24.
Composite of Cardiovascular death, non-fatal Myocardial Infarction, or non-fatal Stroke.
Measured: Week 24.
Hospitalization for Heart Failure.
Measured: Week 24.
Incidence of minor bleeding events defined by the Thrombolysis in Myocardial Infarction Scale.
Measured: On Occurrence (Up to 24 weeks).
Incidence of minimal bleeding events defined by the Thrombolysis in Myocardial Infarction Scale.
Measured: On Occurrence (Up to 24 weeks).
Incidence of major, clinically significant non-major bleeding AND minor bleeding events as defined by the Secondary Bleeding Scale
Measured: On Occurrence (Up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Executive Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677053
- Sponsor's protocol ID
- TAK-442_202
- Other IDs
- U1111-1112-5867
- Status last verified
- Mar 2016
- First submitted
- 9 May 2008
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT00677053
- Acronym / sponsor ID
- TAK-442_202
- Conditions
- Acute Coronary Syndrome
- Keywords
- Unstable Angina, Myocardial Infarction, Thrombolysis, Anticoagulant, Acute Coronary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,753 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| TAK-442 10 mg BID | Experimental | Drug: TAK-442Added with standard care for recurrent ischemic events. |
| TAK-442 20 mg BID | Experimental | Drug: TAK-442Added with standard care for recurrent ischemic events |
| TAK-442 40 mg QD | Experimental | Drug: TAK-442Added with standard care for recurrent ischemic events |
| TAK-442 40 mg BID | Experimental | Drug: TAK-442Added with standard care for recurrent ischemic events |
| TAK-442 80 mg QD | Experimental | Drug: TAK-442Added with standard care for recurrent ischemic events |
| TAK-442 80 mg BID | Experimental | Drug: TAK-442Added with standard care for recurrent ischemic events |
| TAK-442 160 mg QD | Experimental | Drug: TAK-442Added with standard care for recurrent ischemic events |
| TAK-442 120 mg BID | Experimental | Drug: TAK-442Added with standard care for recurrent ischemic events |
| Placebo | Placebo comparator | Drug: PlaceboAdded with standard care for recurrent ischemic events |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Has been hospitalized for acute coronary syndrome
- Is able to initiate study drug if:
- Has at least 1 of the following additional ischemic risk factors:
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-442Stage I: TAK-442 10 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks. | Drug | TAK-442 10 mg BID |
| TAK-442Stage I: TAK-442 20 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks. | Drug | TAK-442 20 mg BID |
| TAK-442Stage I: TAK-442 40 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks. | Drug | TAK-442 40 mg QD |
| TAK-442Stage II: TAK-442 40 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks. | Drug | TAK-442 40 mg BID |
| TAK-442Stage II: TAK-442 80 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks. | Drug | TAK-442 80 mg QD |
| TAK-442Stage II: TAK-442 80 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks. | Drug | TAK-442 80 mg BID |
| TAK-442Stage III: TAK-442 160 mg, capsules, orally, once daily and standard care for recurrent ischemic events for up to 24 weeks. | Drug | TAK-442 160 mg QD |
| TAK-442Stage III: TAK-442 120 mg, capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks. | Drug | TAK-442 120 mg BID |
| PlaceboStages I, II \& III: TAK-442 placebo-matching capsules, orally, twice daily and standard care for recurrent ischemic events for up to 24 weeks. | Drug | Placebo |
Primary outcome
Incidence of Major Bleeding Events defined by the Thrombolysis in Myocardial Infarction Scale.
Time frame: On Occurrence (Up to 24 weeks)
13 secondary outcomes
Composite of Cardiovascular Mortality, non-fatal Myocardial Infarction, non-fatal Stroke, or Myocardial Ischemia requiring hospitalization.
Time frame: Week 24
Cardiovascular Mortality.
Time frame: Week 24.
Non-fatal Myocardial Infarction.
Time frame: Week 24.
Non-fatal Stroke.
Time frame: Week 24.
Myocardial Ischemia requiring hospitalization.
Time frame: Week 24.
All-cause Mortality.
Time frame: Week 24.
Hemorrhagic Mortality.
Time frame: Week 24.
Composite of Cardiovascular death, non-fatal Myocardial Infarction, or Myocardial Ischemia requiring hospitalization.
Time frame: Week 24.
Composite of Cardiovascular death, non-fatal Myocardial Infarction, or non-fatal Stroke.
Time frame: Week 24.
Hospitalization for Heart Failure.
Time frame: Week 24.
Incidence of minor bleeding events defined by the Thrombolysis in Myocardial Infarction Scale.
Time frame: On Occurrence (Up to 24 weeks).
Incidence of minimal bleeding events defined by the Thrombolysis in Myocardial Infarction Scale.
Time frame: On Occurrence (Up to 24 weeks).
Incidence of major, clinically significant non-major bleeding AND minor bleeding events as defined by the Secondary Bleeding Scale
Time frame: On Occurrence (Up to 24 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Executive Medical Director Clinical Science study director
Takeda
103 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-442 in people with Acute Coronary Syndrome, run by Takeda at 103 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United States, India, Russia, Bulgaria, Romania and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Bleeding Events defined by the Thrombolysis in Myocardial Infarction Scale. (time frame: On Occurrence (Up to 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.