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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003235-31-AT

Enrollment

Registered

2005-01-03

Start date

2005-01-31

Completion date

Unknown

Last updated

2022-01-04

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

Conditions

Acute coronary syndrome

Interventions

Trade Name: Lescol Product Name: Lescol Pharmaceutical Form: Tablet INN or Proposed INN: Fluvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Trade Name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: LDL-cholesterol >130 mg/dl 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

Exclusion criteria: STEMI within 1 month prior to enrollment Premonpausal women Systolic BP 10 days prior randomisation Significant valvular disease

Design outcomes

Primary

Measure	Time frame
Main Objective: - Investigation whether fluvastatin and pravastatin have different effects on hsCRP, sCD40L - 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 - Investigation whether add-on therapy with valsartan causes an additional change in endothelial function;Primary end point(s): high-sensitivity C-reactive protein soluble CD40 ligand	—

Measure

Time frame

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

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Countries

Austria

Outcome results

None listed

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