Hypolipemic Treatment in Acute Coronary Syndrome (ACS): Antithrombotic Effects
Effects of Simvastatin Versus Simvastatin Combined With Ezetimibe on Blood Coagulation in Patients With Acute Coronary Events: Relationship With Cholesterol-Lowering and Anti-Inflammatory Properties
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
July 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 10, 2009
February 1, 2009
1 year
July 7, 2008
February 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
decrease in thrombin generation
2 months
Secondary Outcomes (1)
increase in clot permeability
2 months
Study Arms (2)
1
EXPERIMENTALsimvastatin 40g + ezetimibe 10g once a day
2
PLACEBO COMPARATORsimvastatin 40g + placebo once a day
Interventions
Eligibility Criteria
You may qualify if:
- Age \< 75 years
- Acute coronary syndrome (symptom onset \< 12 h)
You may not qualify if:
- Diabetes on insulin
- Anticoagulant therapy
- Renal insufficiency
- Liver injury
- Acute cardiovascular event within the previous 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jagiellonian Universitylead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Institute of Cardiology
Krakow, 31202, Poland
Related Publications (1)
Undas A, Machnik A, Potaczek DP, Wypasek E, Zmudka K, Tracz W. Ezetimibe combined with simvastatin compared with simvastatin alone results in a greater suppression of oxidative stress and enhanced fibrinolysis in patients after acute coronary events. J Cardiovasc Pharmacol. 2011 Aug;58(2):167-72. doi: 10.1097/FJC.0b013e31821e8cb2.
PMID: 21558878DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anetta Undas, Professor
Institute of Cardiology Jagiellonian University Krakow
- STUDY DIRECTOR
Krzysztof Zmudka, Professor
Insitute of Cardiology Jagiellonian University Krakow
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2008
First Posted
July 31, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2009
Study Completion
December 1, 2009
Last Updated
February 10, 2009
Record last verified: 2009-02