The Impact of Tredaptive on Flow-Mediated Dilation in Cardiac Patients

NCT01052311 | Terminated Phase 4

• 1 other identifier: SHEBA-09-7418-MS-CTIL
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Coronary Artery Disease; Dyslipidemia

Keywords

Coronary artery disease; Endothelial function; Platelet function; Statins; Niacin

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  3 months.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo pills once daily

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.

Drug: Tredaptive (1 g extended release niacin+ 20 mg laropiprant); Drug: Tredaptive

Interventions

Tredaptive (1 g extended release niacin+ 20 mg laropiprant) DRUG

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.

Also known as: Active treatment

Active treatment

Placebo DRUG

Placebo tablets once daily

Placebo

Tredaptive DRUG

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.

Also known as: Tedaptive

Active treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Leviev Heart Center, Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Coronary Artery Disease; Dyslipidemias

Interventions

MK-0524

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael Shechter, MD, MA

  Leviev Heart Center, Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Shlomi Matetzky, MD

  Leviev Heart Center, Sheba Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2010
• First Posted: January 20, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 19, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)