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

Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease; Dyslipidemia

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

Phase: Phase 4

Status: Terminated

Sponsored by: Sheba Medical Center

Official(s) and/or principal investigator(s):
Michael Shechter, MD, MA, Principal Investigator, Affiliation: Leviev Heart Center, Sheba Medical Center
Shlomi Matetzky, MD, Study Director, Affiliation: Leviev Heart Center, Sheba Medical Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: 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.

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.

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 .

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion criteria: 1. Male or female ≥ 18 years; signed informed consent 2. Outpatient CAD patients on statin therapy. 3. HDL-C < 40 mg/dL in males and < 50 mg/dL in females. 4. Left ventricular (LV) systolic dysfunction ≥ 40% measured within the past 6 months. 5. No changes in cardiac medications during 2 weeks prior to enrollment. Exclusion criteria: 1. Presence of transplanted tissue or organ or LVAD 2. AICD or CRT or CRTD patients. 3. Acute MI, CABG, PCI within past 3 months. 4. Congestive heart failure (CHF) ≥ NYHA 2. 5. Ejection fraction < 40% measured within the past 6 months. 6. Malignancy. 7. Active myocarditis, or cardiomyopathy. 8. HIV infection or immunodeficiency state. 9. Chronic viral infection. 10. Acute systemic infection requiring antibiotics. 11. Chronic diarrhea or malabsorption. 12. Statin therapy initiation ≤ 3 months. 13. Diabetes mellitus type 1. 14. Diabetes mellitus type 2 with HbA1C > 7% 15. Low-density lipoprotein cholesterol (LDL-C) > 100 mg/dL. 16. Not on statin therapy. 17. Liver function tests (LFT) ≥ x 3 upper limit of normal (ULN) or creatinine kinase (CPK) ≥ x 10 ULN. 18. Hypo/hyper thyroidism. 19. Liver dysfunction. 20. Renal failure with serum creatinine ≥ 2 mg/dL. 21. Alcohol or drug abuse. 22. Refuse to sign informed consent.

Locations and Contacts

Leviev Heart Center, Sheba Medical Center, Tel Hashomer 52621, Israel
Additional Information

The Clinical Research Unit and Leviev Heart Center

Starting date: July 2010
Last updated: April 21, 2013

Page last updated: August 23, 2015

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