Hypolipemic Treatment in Acute Coronary Syndrome (ACS): Antithrombotic Effects

NCT00725829 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-02-10

No results posted yet for this study

Summary

The aim of the current study is to evaluate whether treatment with high doses of simvastatin can reduce coagulation activation in patients with acute coronary syndromes and if ezetimibe in conjunction with simvastatin may affect blood clotting in a similar manner.

The investigators hypotheses are as follows:

1. Intensive lipid lowering treatment with simvastatin (40 mg/day) and simvastatin (40 mg/day) combined with ezetimibe (10 mg/day) initiated after acute coronary syndrome leads to attenuation of blood coagulation including reduced thrombin generation, thrombin-mediated coagulant reactions, and improved structure of plasma clots.
2. Anticoagulant effects of simvastatin are weaker than those observed during administration of simvastatin and ezetimibe.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

simvastatin

Simvastatin 40mg/d

DRUG

ezetimibe

ezetimibe 10mg/d

DRUG

placebo

placebo

Sponsors & Collaborators

Principal Investigators

  • Anetta Undas, Professor · Institute of Cardiology Jagiellonian University Krakow

  • Krzysztof Zmudka, Professor · Insitute of Cardiology Jagiellonian University Krakow

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-06-30
Completion
2009-12-31

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00725829 on ClinicalTrials.gov