Coronary Artery DiseasePhase 4NCT01052311
The Impact of Tredaptive on Flow-Mediated Dilation in Cardiac Patients
A Phase 4 study testing Tredaptive (1 g extended release niacin+ 20 mg laropiprant) and Tredaptive in people with Coronary Artery Disease and Dyslipidemia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Laropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) offers improved tolerability, supporting a simplified 1-2 g dosing paradigm and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Dyslipidemia
- What is being tested?
- Tredaptive (1 g extended release niacin+ 20 mg laropiprant) and Tredaptive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Jan 2013
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years; signed informed consent
- Outpatient CAD patients on statin therapy.
- HDL-C < 40 mg/dL in males and < 50 mg/dL in females.
- Left ventricular (LV) systolic dysfunction ≥ 40% measured within the past 6 months.
- No changes in cardiac medications during 2 weeks prior to enrollment.
Who cannot join
- Presence of transplanted tissue or organ or LVAD
- AICD or CRT or CRTD patients.
- Acute MI, CABG, PCI within past 3 months.
- Congestive heart failure (CHF) ≥ NYHA 2.
- Ejection fraction < 40% measured within the past 6 months.
- Malignancy.
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- Active myocarditis, or cardiomyopathy.
- HIV infection or immunodeficiency state.
- Chronic viral infection.
- Acute systemic infection requiring antibiotics.
- Chronic diarrhea or malabsorption.
- Statin therapy initiation ≤ 3 months.
- Diabetes mellitus type 1.
- Diabetes mellitus type 2 with HbA1C > 7%
- Low-density lipoprotein cholesterol (LDL-C) > 100 mg/dL.
- Not on statin therapy.
- Liver function tests (LFT) ≥ x 3 upper limit of normal (ULN) or creatinine kinase (CPK) ≥ x 10 ULN.
- Hypo/hyper thyroidism.
- Liver dysfunction.
- Renal failure with serum creatinine ≥ 2 mg/dL.
- Alcohol or drug abuse.
- Refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Tredaptive (ER Niacin/Laropiprant) Compared to Placebo on Brachial Artery Endothelial Function in Patients With Stable Coronary Artery Disease on Statin Therapy
Laropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) offers improved tolerability, supporting a simplified 1-2 g dosing paradigm and improved adherence. Statins and niacin improve endothelial function in cardiac patients, however, there is no data yet regarding the additive effects of raising HDL-C by ERN/LRPT and statins on endothelial function in cardiac patients. Thus the aim of the present study is to evaluate the impact of 3 months' administration of ERN/LRPT compared to placebo added to statins on endothelial function, assessed by brachial artery vasoreactivity in stable cardiac patients.
Read the detailed description
Endothelial dysfunction reflects a vascular phenotype prone to atherogenesis and may therefore serve as a marker of an inherent atherosclerotic risk. In line with this hypothesis, dysfunction of either the coronary or peripheral vascular endothelium was shown to constitute an independent predictor of cardiovascular events, providing valuable prognostic information additional to that derived from conventional risk factor assessment. Interventions, such as risk factor modification and treatment with various drugs, including statins and niacin, may improve endothelial function leading potentially to improve prognosis.
Research over the past years has identified numerous beneficial effects of high-density lipoprotein (HDL) beyond this property. These include, but not limited to, improvement of endothelial function, anti-inflammatory, anti-thrombotic, antioxidative effects and the stimulation of endothelial regeneration. Consequently, therapeutic elevation of HDL is among the primary goals of treatment of patients with coronary artery disease (CAD). Laropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) offers improved tolerability, supporting a simplified 1-2 g dosing paradigm and improved adherence. Statins and niacin improve endothelial function in CAD patients, however, there is no data yet regarding the additive effects of raising HDL-C by ERN/LRPT and statins on endothelial function in CAD patients. Thus the aim of the present study is to evaluate the impact of 3 months' administration of ERN/LRPT compared to placebo added to statins on endothelial function, assessed by brachial artery vasoreactivity, and platelet function in stable CAD patients .
- Conditions
- Coronary Artery Disease, Dyslipidemia
- Being tested
- Tredaptive (1 g extended release niacin+ 20 mg laropiprant), Placebo, Tredaptive
- Keywords
- Coronary artery disease, Endothelial function, Platelet function, Statins, Niacin
- Medical subject headings
- Coronary Artery Disease, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tredaptive (1 g extended release niacin+ 20 mg laropiprant)Drug
Also called Active treatment
Laropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) once daily for the first 30 days. from day 31 to 90 it will be 2 g of extended-release niacin and 20 mg laropiprant once daily.
PlaceboDrug
Placebo tablets once daily
TredaptiveDrug
Also called Tedaptive
Tredaptive 1 g [Laropiprant 20 mg(LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) and 1 g of extended-release niacin]from day 1 to 30 once daily. From day 31 to 90, the same but 2 g instead of 1 g of extended-release niacin.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo pills once daily Receives: Drug: Placebo |
| Active treatment | Active comparator | Laropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) = tredaptive once daily from day 1 to 30. From day 31 to day 90 2 g of extended-release niacin and 20 mg of laropiprant once daily. Receives: Drug: Tredaptive (1 g extended release niacin+ 20 mg laropiprant); Drug: Tredaptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of 3 months' administration of ERN/LRPT compared to placebo added to statins on endothelial function, assessed by brachial artery vasoreactivity in stable CAD patients.
Measured: 3 months
Secondary outcomes (1)
To evaluate the impact of 3 months' administration of ERN/LRPT compared to placebo added to statins on platelet function in stable CAD patients.
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: The sponsor decided to withdraw study drug from market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michael Shechter, MD, MA, Principal investigator, Leviev Heart Center, Sheba Medical CenterShlomi Matetzky, MD, Study director, Leviev Heart Center, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052311
- Sponsor's protocol ID
- SHEBA-09-7418-MS-CTIL
- Status last verified
- Oct 2016
- First submitted
- 16 Jan 2010
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Tredaptive (ER Niacin/Laropiprant) Compared to Placebo on Brachial Artery Endothelial Function in Patients With Stable Coronary Artery Disease on Statin Therapy
- ClinicalTrials.gov ID
- NCT01052311
- Acronym / sponsor ID
- SHEBA-09-7418-MS-CTIL
- Conditions
- Coronary Artery Disease, Dyslipidemia
- Keywords
- Coronary artery disease, Endothelial function, Platelet function, Statins, Niacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to withdraw study drug from market
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Jan 2010 (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.
Laropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) offers improved tolerability, supporting a simplified 1-2 g dosing paradigm and improved adherence. Statins and niacin improve endothelial function in cardiac patients, however, there is no data yet regarding the additive effects of raising HDL-C by ERN/LRPT and statins on endothelial function in cardiac patients. Thus the aim of the present study is to evaluate the impact of 3 months' administration of ERN/LRPT compared to placebo added to statins on endothelial function, assessed by brachial artery vasoreactivity in stable cardiac patients.
Detailed description
Endothelial dysfunction reflects a vascular phenotype prone to atherogenesis and may therefore serve as a marker of an inherent atherosclerotic risk. In line with this hypothesis, dysfunction of either the coronary or peripheral vascular endothelium was shown to constitute an independent predictor of cardiovascular events, providing valuable prognostic information additional to that derived from conventional risk factor assessment. Interventions, such as risk factor modification and treatment with various drugs, including statins and niacin, may improve endothelial function leading potentially to improve prognosis.
Research over the past years has identified numerous beneficial effects of high-density lipoprotein (HDL) beyond this property. These include, but not limited to, improvement of endothelial function, anti-inflammatory, anti-thrombotic, antioxidative effects and the stimulation of endothelial regeneration. Consequently, therapeutic elevation of HDL is among the primary goals of treatment of patients with coronary artery disease (CAD). Laropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) offers improved tolerability, supporting a simplified 1-2 g dosing paradigm and improved adherence. Statins and niacin improve endothelial function in CAD patients, however, there is no data yet regarding the additive effects of raising HDL-C by ERN/LRPT and statins on endothelial function in CAD patients. Thus the aim of the present study is to evaluate the impact of 3 months' administration of ERN/LRPT compared to placebo added to statins on endothelial function, assessed by brachial artery vasoreactivity, and platelet function in stable CAD patients .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pills once daily |
| Active treatment | Active comparator | Drug: Tredaptive (1 g extended release niacin+ 20 mg laropiprant), Drug: TredaptiveLaropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) = tredaptive once daily from day 1 to 30. From day 31 to day 90 2 g of extended-release niacin and 20 mg of laropiprant once daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥ 18 years; signed informed consent
- Outpatient CAD patients on statin therapy.
- HDL-C < 40 mg/dL in males and < 50 mg/dL in females.
- Left ventricular (LV) systolic dysfunction ≥ 40% measured within the past 6 months.
- No changes in cardiac medications during 2 weeks prior to enrollment.
Key exclusion criteria (22 listed)
- Presence of transplanted tissue or organ or LVAD
- AICD or CRT or CRTD patients.
- Acute MI, CABG, PCI within past 3 months.
- Congestive heart failure (CHF) ≥ NYHA 2.
- Ejection fraction < 40% measured within the past 6 months.
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 |
|---|---|---|
| Tredaptive (1 g extended release niacin+ 20 mg laropiprant)Also: Active treatmentLaropiprant (LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) is a potent, once-daily, highly selective PGD2-receptor (DP1) antagonist. A combination tablet containing 1 g of extended-release niacin and 20 mg of laropiprant (ERN/LRPT) once daily for the first 30 days. from day 31 to 90 it will be 2 g of extended-release niacin and 20 mg laropiprant once daily. | Drug | Active treatment |
| PlaceboPlacebo tablets once daily | Drug | Placebo |
| TredaptiveAlso: TedaptiveTredaptive 1 g [Laropiprant 20 mg(LRP; Merck \& Co., Inc, Whitehouse Station, NJ, USA) and 1 g of extended-release niacin]from day 1 to 30 once daily. From day 31 to 90, the same but 2 g instead of 1 g of extended-release niacin. | Drug | Active treatment |
Primary outcome
To evaluate the impact of 3 months' administration of ERN/LRPT compared to placebo added to statins on endothelial function, assessed by brachial artery vasoreactivity in stable CAD patients.
Time frame: 3 months
1 secondary outcome
To evaluate the impact of 3 months' administration of ERN/LRPT compared to placebo added to statins on platelet function in stable CAD patients.
Time frame: 3 months.
Results and safety
The study was stopped early (reason given: The sponsor decided to withdraw study drug from market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Michael Shechter, MD, MA principal investigator
Leviev Heart Center, Sheba Medical Center
Shlomi Matetzky, MD study director
Leviev Heart Center, Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tredaptive (1 g extended release niacin+ 20 mg laropiprant) and Tredaptive in people with Coronary Artery Disease and Dyslipidemia, run by Sheba Medical Center at 1 site in Israel.
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 5 inclusion and 22 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: stopped early, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: The sponsor decided to withdraw study drug from market). 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?
To evaluate the impact of 3 months' administration of ERN/LRPT compared to placebo added to statins on endothelial function, assessed by brachial artery vasoreactivity in stable CAD patients. (time frame: 3 months). 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 19 Oct 2016.