Effect of pravastatin or fluvastatin and add-on valsartan on inflammatory markers and peripheral endothelial function in patients with acute coronary syndrome

Phase 1

• Conditions: Acute coronary syndrome; patients with NSTEMI

• Registration Number: EUCTR2004-003235-31-AT
• Lead Sponsor: Div. of Cardiology, Innsbruck Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-01-03
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

LDL-cholesterol >130 mg/dl <=250 mg/dl
Acute coronary syndrome (NSTEMI, unstable angina pectoris)
age > 18 years
Left ventricular EF>40%
Signed informed consent
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

STEMI within 1 month prior to enrollment
Premonpausal women
Systolic BP <100 mmHg
Active liver disease or hepatic dysfunction
Severe renal dysfunction
Statin treatment >10 days prior randomisation
Significant valvular disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - Investigation whether fluvastatin and pravastatin have different effects on hsCRP, sCD40L <br>- Investigation whether add-on therapy with valsartan causes an additional decrease of hsCRP and sCD40L;Secondary Objective: -Investigation whether fluvastatin and pravastatin have different effects on endothelial function<br>- Investigation whether add-on therapy with valsartan causes an additional change in endothelial function;Primary end point(s): high-sensitivity C-reactive protein<br>soluble CD40 ligand