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

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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.