PRevention of Atherosclerosis In High-Risk Patients: Aggressive Risk Modification including NiAspan - PRIMA
- Conditions
- Patients at high risk for CVD
- Registration Number
- EUCTR2005-005563-28-DE
- Lead Sponsor
- niversity Clinic Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
· Agatston calcium score >30, or· CAC > 100 or >75th percentile
· HDL <40mg/dl in men and < 50mg/dl in women
· Normal renal function
· Normal liver blood tests
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
· Post event CHD (post MI, revascularization, stroke)
· Unstable Angina Pectoris
· Past or current peptic ulcers
· Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method