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

Phase 1

Completed

• Conditions: Acute Coronary Syndrome; Angioplasty, Transluminal, Percutaneous Coronary; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Blood Platelets
• Interventions: Drug: placebo; Drug: rosuvastatin

• Registration Number: NCT01241903
• Lead Sponsor: Susan Smyth

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Study Start: 2011-06
• Primary Completion: 2013-08
• Study Completion: 2014-02
• Results First Submitted: 2014-05-21
• Results First Submitted QC: 2014-05-21
• Results First Posted: 2014-06-24
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-26
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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
• Dehydration
• Trauma
• Severe metabolic, endocrine or electrolyte abnormality
• Recent (within the last 2 weeks) or planned (in the next month) major surgery
• HIV/AIDS with current of planned use of HIV protease inhibitors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	placebo	-
Crestor	rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Platelet - Leukocyte Aggregates	within first 24 hours	measured by flow cytometry

Secondary Outcome Measures

Name	Time	Method
Biomarkers of Platelet Function and Myocardial Necrosis	up to 30 days

Trial Locations

Locations (1)

University of Kentucky Dept of Cardiology; 🇺🇸 Lexington, Kentucky, United States