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COMPLETEDPHASE1

Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions

Early Use of Rosuvastatin (Crestor) in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions

NCT01241903•Susan Smyth

Summary

The central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. The primary objective of the study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must be between 18 and 80 years old.
•2. Subjects must be willing and able to give informed consent
•3. A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.
•4. Subjects must have symptoms of acute coronary syndrome as defined by 2 of the 3: (a) history of cardiac-ischemia-related symptoms of at least 10 minutes duration ≤ 8 hours prior to randomized treatment assignment (b) concurrent biomarker evidence of cardiac ischemia, as defined by troponin I or T greater that upper limit of normal (ULN) or creatine kinase-myocardial band (CK-MB) greater than ULN. (c) concurrent electrocardiographic evidence of cardiac ischemia, as defined by new of presumably new ST-segment depression (≥1 mm) or transient (\<30 min) ST-segment elevation (≥ 1mm) in at least two contiguous leads.
•5. Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)

Exclusion Criteria

•Age \<18 years
•Age \> 80 years
•Use of Crestor in the past 30 days
•GFR (estimated) \<30 ml/min
•Hemodialysis
•History of liver failure
•Unexplained liver function abnormalities
•Current or planned use of cyclosporine or gemfibrozil
•Sepsis
•Hypotension
+5 more criteria

Locations (1)

University of Kentucky Dept of Cardiology

Lexington, Kentucky, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

August 1, 2013

Completion Date

February 1, 2014

Last Updated

March 28, 2017

Enrollment

ACTUAL participants

Conditions

Acute Coronary SyndromeAngioplasty, Transluminal, Percutaneous CoronaryHydroxymethylglutaryl-CoA Reductase InhibitorsBlood Platelets

Interventions

rosuvastatin

DRUG

placebo

DRUG

Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction

NCT07436429

Myocardial Infarction (MI)ST-Elevation Myocardial Infarction+3 more

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RECRUITINGNA

Evaluation Through Innovative Examinations of Intestinal Dysbiosis Status in Patients Diagnosed With Cardiovascular Diseases and Evaluation of the Efficacy of Natural and Probiotic Extracts in the Non-pharmacological Approach to Improving Intestinal Dysbiosis Status.

NCT07429227

Acute Coronary Syndromes (ACS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions

Inclusion Criteria

Exclusion Criteria

Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction

Evaluation Through Innovative Examinations of Intestinal Dysbiosis Status in Patients Diagnosed With Cardiovascular Diseases and Evaluation of the Efficacy of Natural and Probiotic Extracts in the Non-pharmacological Approach to Improving Intestinal Dysbiosis Status.

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

A Polypill for Acute Coronary Syndrome