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Fluvastatin in the therapy of acute coronary syndrome

Fluvastatin in the therapy of acute coronary syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81331696
Enrollment
1000
Registered
2005-03-22
Start date
2003-01-01
Completion date
Unknown
Last updated
2020-02-03

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

Conditions

Acute coronary syndrome (ACS) Circulatory System Coronary diseases

Interventions

Patients are randomized at admission to 80 mg fluvastatin (Lescol XL) or to placebo immediately orally (po) and then once daily for 30 days. Patients are followed up for 360 days.

Sponsors

Novartis Pharma CR s.r.o.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible patients with ST elevation ACS must have resting chest pain less than 12 hours before admission and either >1 mm ST-segment elevation in 2 or more continuous leads or new left bundle branch block on electrocardiogram (ECG). Those with non-ST elevation ACS must have resting chest pain during the previous 48 hours and either >1 mm ST segment depression or negative T waves in 2 or more continuous leads.

Exclusion criteria

Exclusion criteria: Does not match inclusion criteria

Design outcomes

Primary

MeasureTime frame
Influence of fluvastatin therapy on levels of inflammatory markers (CRP and interleukin-6) and on pregnancy associated plasma protein A (PAPP-A)

Secondary

MeasureTime frame
A combined secondary endpoint is 30-day and one-year occurrence of death, nonfatal myocardial infarction, recurrent symptomatic ischemia, urgent revascularization, and cardiac arrest.

Countries

Czech Republic, Slovakia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026