Status:
TERMINATED
Nicotinic Acid Composition of HDL and Arterial Endothelium Function in Premature Coronary Heart Disease and High HDL
Lead Sponsor:
Xavier Pinto Sala
Conditions:
Dyslipidemias
Eligibility:
All Genders
25+ years
Phase:
PHASE4
Brief Summary
Patients with premature ischemic heart disease (PIHD) and elevated levels of HDL-C present an altered composition of high-density lipoproteins (HDL) which is associated with a loss of their anti-ather...
Eligibility Criteria
Inclusion
- Being male or female
- Age \> 25 years
- Have an episode of ischemic heart disease before 55 years in men and in women 65 years
- Serum HDL-C above the 90th percentile of the Spanish population: \>=2.0mmol/L in women and \>=1.8mmol/L in men (Gomez-Gerique JA, et al. Med Clin (Barc.). 1999, 113: 730-735.)
- Stable treatment with any statin in the past 6 weeks: simvastatin, atorvastatin, rosuvastatin, pravastatin or lovastatin.
Exclusion
- Uncontrolled hypercholesterolemia or hypertriglyceridemia, LDL-C \>2.6mmol/L or triglycerides \>2.24mmol/L
- Patients with an episode of ischemic heart disease in the last 3 months
- Patients suffering from acute or chronic inflammatory diseases in the last 3 months
- Treatment with fibrates or omega-3 fatty acids.
- Treatment with steroids or immunosuppressive drugs
- Patients with a contraindication to Tredaptive (Hypersensitivity to the active substances or any of the excipients, significant or unexplained hepatic dysfunction, active peptic ulcer, arterial bleeding).
- Patients treated with drugs that may interact with Tredaptive (Midazolam).
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01450410
Start Date
July 1 2012
End Date
May 1 2013
Last Update
January 29 2013
Active Locations (1)
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1
Unitat Funcional de Risc Vascular. Servei Medicina Interna. Hospital Universitari de Bellvitge.
L'Hospitalet de Llobregat, Barcelona, Spain, 08907