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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Jagiellonian University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT00725829
First received: July 7, 2008
Last updated: February 9, 2009
Last verified: February 2009
  Purpose

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.

Condition Intervention
Acute Coronary Syndrome
Drug: simvastatin
Drug: ezetimibe
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • decrease in thrombin generation [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • increase in clot permeability [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
simvastatin 40g + ezetimibe 10g once a day
Drug: simvastatin
Simvastatin 40mg/d
Drug: ezetimibe
ezetimibe 10mg/d
Placebo Comparator: 2
simvastatin 40g + placebo once a day
Drug: simvastatin
Simvastatin 40mg/d
Drug: placebo
placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age < 75 years
  • Acute coronary syndrome (symptom onset < 12 h)

Exclusion Criteria:

  • Diabetes on insulin
  • Anticoagulant therapy
  • Renal insufficiency
  • Liver injury
  • Acute cardiovascular event within the previous 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725829

Locations
Poland
Institute of Cardiology Recruiting
Krakow, Poland, 31202
Contact: Anetta Undas, MD, PhD    +48126143004    anettaundas@yahoo.com   
Principal Investigator: Anetta Undas, MD , PhD         
Sponsors and Collaborators
Jagiellonian University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Anetta Undas, Professor Institute of Cardiology Jagiellonian University Krakow
Study Director: Krzysztof Zmudka, Professor Insitute of Cardiology Jagiellonian University Krakow
  More Information

No publications provided

Responsible Party: Anetta Undas, Jagiellonian University School of Medicine
ClinicalTrials.gov Identifier: NCT00725829     History of Changes
Other Study ID Numbers: Prot. 116
Study First Received: July 7, 2008
Last Updated: February 9, 2009
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
coagulation
cholesterol
acute ischemia
fibrin clot

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Ezetimibe
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014