Acute Coronary SyndromePhase 3NCT00353067
Veliflapon (DG-031)to Prevent Heart Attacks or Stroke in Patients With a History of Heart Attack or Unstable Angina
A Phase 3 study testing veliflapon (DG-031) in people with Acute Coronary Syndrome, run by deCODE genetics at 11 sites in United States.
Trial summary
The purpose of this study is to determine if veliflapon (DG-031)can prevent a heart attack or stroke in African American patients with a history of unstable angina or myocardial infarction. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- veliflapon (DG-031)
- How many people
- 3,450 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2006to not given
- Phase
- Phase 3
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- 35 years of age or older
- African American by self-report.
- A history of either acute MI or admission for unstable angina (UA)within 30 days of randomization
- Women who have undergone surgical sterilization (hysterectomy or bilateral tubal ligation or bilateral oophorectomy)or are > 2 years post-menopausal by medical history are also eligible.
- Women of childbearing potential must have a negative urine pregnancy test and are required to use 2 barrier methods of contraception throughout the study.
- Patients are capable of understanding study procedures and agree to participate in the study including scheduled follow up visits and consent to genetic haplotype testing.
Who cannot join
- Presence of active, symptomatic HF defined by presence of New York Heart Association Class II-IV at time of screening.
- Received any treatment with an investigational agent or device within 4 weeks.
- Evidence of secondary angina or ischemia
- Underlying cardiac disorders that may cause cardiac ischemia including aortic stenosis or hypertrophic cardiomyopathy.
- Presence of active hepatic disease or AST and/or ALT > 3.0 × ULN.
- Calculated creatinine clearance < 30 ml/minute OR the presence of chronic and severe renal insufficiency.
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- Major surgery performed within six weeks prior to scheduled day of randomization.
- Any other major intercurrent illness and other condition, which, in the opinion of the Investigator, will interfere with the patient's participation in the study or leads to a survival prognosis of < 5 years.
- A history of additional risk factors for Torsades de Pointe (TdP)
- Patients who are not willing to return for follow up visits or with a known history of non-compliance.
- Patients who consume > 3 alcoholic drinks/day or > 15 drinks/week, or have a history of alcohol abuse within the past 2 years.
- History of active drug abuse within 1 year of screening for the study.
- Pregnant or lactating women.
- Poor mental function or any other reason that may cause difficulty in complying with the requirements of the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Carrollton, Texas, 75007
Study site
Fort Worth, Texas, 76104
Study site
Hopewell, Virginia, 23860
Study site
Jacksonville, Florida, 32216
Study site
Melrose Park, Illinois, 60160
Study site
Montgomery, Alabama, 36106
Study site
Nashville, Tennessee, 37203
Study site
Oklahoma City, Oklahoma, 73103
Study site
Philadelphia, Pennsylvania, 19142
Study site
Richardson, Texas, 75080
Study site
Suffolk, Virginia, 23434
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Veliflapon (DG-031) in Reducing the Risk of Acute Cardiovascular Events in African American Patients With Coronary Artery Disease(The LTCAD Study).
The purpose of this study is to determine if veliflapon (DG-031)can prevent a heart attack or stroke in African American patients with a history of unstable angina or myocardial infarction.
Read the detailed description
Genetic linkage and association studies in Icelandic patients with a history of myocardial infarction and stroke showed common haplotypes in two genes, 5-lipoxygenase activating protein(FLAP)and Leukotriene A4 Hydrolase(LTA4H), that each conferred significant risk for MI and stroke. The FLAP haplotype had a RR of 1.8 for MI and 2.1 for those with MI and stroke. LTA4H haplotype had a RR of 1.1 for MI and 1.5 for MI and stroke.Both gene associations were replicated in European and US Caucasian groups and were independent of the conventional risk factors such as LDL-cholesterol, hypertension, and diabetes. The haplotype for the LTA4H pathway showed a modest relative risk of 1.2 in US Caucasian cohorts for all MI and 1.4 for MI and stroke. However, the LTA4H haplotype had a much higher relative risk of 3.5 for myocardial infarction in African-Americans (p=0.000022).
Self identified African American patients with acute coronary syndrome (ACS) were selected for this study as this population has the highest risk identified to date for developing an MI related to the HapK genetic variant in the leukotriene pathway. The study will be enriched to include African American patients randomized by an algorithm designed to assure that approximately 80% of the study population will be Hap K positive and 20% will not have the Hap K positive result.
All patients will be screened for eligibility based on the haplotype status. Patients will be randomized to either veliflapon or placebo on top of standard care. Patients are randomized within 5-30 days of their ACS event.
This is an events driven study with the time of the first occurrence of any of the following elements: hospitalization for UA or urgent revascularization, fatal/non-fatal MI, fatal/non-fatal stroke and CV related death comprising the primary endpoint. The primary null hypothesis of efficacy is that time to first CV event among African American patients with a positive LTA4H HapK Variant assay test is no different from placebo when either is given in addition to standard of care therapy. A total of 3450 eligible patients will be randomized in this study.
The treatment duration for patients enrolled in the study will be a target of at least 6 months (based on approximate time of last patient enrolled) and up to 36 months (from first patient enrolled). All cardiac clinical events endpoints will be adjudicated by an independent Clinical Endpoint Committee (CEC).
- Conditions
- Acute Coronary Syndrome
- Being tested
- veliflapon (DG-031)
- Keywords
- unstable angina, myocardial infarction, coronary thrombosis, coronary atherosclerosis
- Medical subject headings
- Acute Coronary Syndrome, Angina, Unstable, Myocardial Infarction, Coronary Thrombosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
veliflapon (DG-031)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of a composite endpoint including:hospitalization for unstable angina or urgent revascularization; fatal/non-fatal MI; fatal/non-fatal stroke or CV related death
Secondary outcomes (2)
Time to first occurrence of each of the following: an acute CV event (one of the composite CV events) among ALL randomized patients; MI, fatal and non-fatal
Stroke, fatal and non-fatal; CV related death and all cause mortality.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startMay 2006
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 3,450 participants
Sponsor and investigators
- Lead sponsor
- deCODE genetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henry Ford Health System, Duke University
- Investigators
- Douglas W Weaver, M.D., Principal investigator, Henry Ford HospitalChristopher Granger, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353067
- Sponsor's protocol ID
- DG-031-CV-301
- Status last verified
- Nov 2006
- First submitted
- 14 Jul 2006
- Last updated
- 29 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Veliflapon (DG-031) in Reducing the Risk of Acute Cardiovascular Events in African American Patients With Coronary Artery Disease(The LTCAD Study).
- ClinicalTrials.gov ID
- NCT00353067
- Acronym / sponsor ID
- DG-031-CV-301
- Conditions
- Acute Coronary Syndrome
- Keywords
- unstable angina, myocardial infarction, coronary thrombosis, coronary atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 3,450 participants
- Lead sponsor
- deCODE geneticsIndustry (pharma, biotech, devices)
- Collaborators
- Henry Ford Health System, Duke University
- Study start
- May 2006
- First posted
- 17 Jul 2006 (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 if veliflapon (DG-031)can prevent a heart attack or stroke in African American patients with a history of unstable angina or myocardial infarction.
Detailed description
Genetic linkage and association studies in Icelandic patients with a history of myocardial infarction and stroke showed common haplotypes in two genes, 5-lipoxygenase activating protein(FLAP)and Leukotriene A4 Hydrolase(LTA4H), that each conferred significant risk for MI and stroke. The FLAP haplotype had a RR of 1.8 for MI and 2.1 for those with MI and stroke. LTA4H haplotype had a RR of 1.1 for MI and 1.5 for MI and stroke.Both gene associations were replicated in European and US Caucasian groups and were independent of the conventional risk factors such as LDL-cholesterol, hypertension, and diabetes. The haplotype for the LTA4H pathway showed a modest relative risk of 1.2 in US Caucasian cohorts for all MI and 1.4 for MI and stroke. However, the LTA4H haplotype had a much higher relative risk of 3.5 for myocardial infarction in African-Americans (p=0.000022).
Self identified African American patients with acute coronary syndrome (ACS) were selected for this study as this population has the highest risk identified to date for developing an MI related to the HapK genetic variant in the leukotriene pathway. The study will be enriched to include African American patients randomized by an algorithm designed to assure that approximately 80% of the study population will be Hap K positive and 20% will not have the Hap K positive result.
All patients will be screened for eligibility based on the haplotype status. Patients will be randomized to either veliflapon or placebo on top of standard care. Patients are randomized within 5-30 days of their ACS event.
This is an events driven study with the time of the first occurrence of any of the following elements: hospitalization for UA or urgent revascularization, fatal/non-fatal MI, fatal/non-fatal stroke and CV related death comprising the primary endpoint. The primary null hypothesis of efficacy is that time to first CV event among African American patients with a positive LTA4H HapK Variant assay test is no different from placebo when either is given in addition to standard of care therapy. A total of 3450 eligible patients will be randomized in this study.
The treatment duration for patients enrolled in the study will be a target of at least 6 months (based on approximate time of last patient enrolled) and up to 36 months (from first patient enrolled). All cardiac clinical events endpoints will be adjudicated by an independent Clinical Endpoint Committee (CEC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women
- 35 years of age or older
- African American by self-report.
- A history of either acute MI or admission for unstable angina (UA)within 30 days of randomization
- Women who have undergone surgical sterilization (hysterectomy or bilateral tubal ligation or bilateral oophorectomy)or are > 2 years post-menopausal by medical history are also eligible.
Key exclusion criteria (14 listed)
- Presence of active, symptomatic HF defined by presence of New York Heart Association Class II-IV at time of screening.
- Received any treatment with an investigational agent or device within 4 weeks.
- Evidence of secondary angina or ischemia
- Underlying cardiac disorders that may cause cardiac ischemia including aortic stenosis or hypertrophic cardiomyopathy.
- Presence of active hepatic disease or AST and/or ALT > 3.0 × ULN.
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 |
|---|---|---|
| veliflapon (DG-031) | Drug | – |
Primary outcome
Time to first occurrence of a composite endpoint including:hospitalization for unstable angina or urgent revascularization; fatal/non-fatal MI; fatal/non-fatal stroke or CV related death
2 secondary outcomes
Time to first occurrence of each of the following: an acute CV event (one of the composite CV events) among ALL randomized patients; MI, fatal and non-fatal
Stroke, fatal and non-fatal; CV related death and all cause mortality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2006.
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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.
Douglas W Weaver, M.D. principal investigator
Henry Ford Hospital
Christopher Granger, M.D. principal investigator
Duke University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing veliflapon (DG-031) in people with Acute Coronary Syndrome, run by deCODE genetics at 11 sites in United States.
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 7 inclusion and 14 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: paused, as of the sponsor's last update on 29 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Time to first occurrence of a composite endpoint including:hospitalization for unstable angina or urgent revascularization; fatal/non-fatal MI; fatal/non-fatal stroke or CV related death. 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 29 Nov 2006.