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PRevention of Atherosclerosis In High-Risk Patients: Aggressive Risk Modification including NiAspan - PRIMA

PRevention of Atherosclerosis In High-Risk Patients: Aggressive Risk Modification including NiAspan - PRIMA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005563-28-DE
Enrollment
160
Registered
2006-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients at high risk for CVD

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: nicotinic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical Form: Tablet INN or Proposed IN

Sponsors

University Clinic Essen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: · Agatston calcium score >30, or· CAC > 100 or >75th percentile · HDL =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: · Post event CHD (post MI, revascularization, stroke) · Unstable Angina Pectoris · Past or current peptic ulcers · Pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: To prove a positive influence on HDL-raising by nIaspan on the development of arteriosclerosis in high-risk pattients under aggressive risk modulation;Secondary Objective: Not applicable;Primary end point(s): Difference in coronary artery calcium, determined by electron beam computed tomography (EBCT), after 2 years of treatment—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026