Effects of Atorvastatin on Myonecrosis

NCT00344019 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2006P000035
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a prospective, randomized, placebo-controlled, double-blind analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to percutaneous coronary intervention \[PCI\] (at least 2 hours) in patients presenting with unstable angina. Only patients with negative cardiac biomarkers, measured on 2 separate occasions a few hours apart will be eligible for inclusion. Furthermore, patients already on high-dose statin therapy; patients taking any statin within 24 hours prior to the PCI; and patients with contraindications to statins will be excluded from the study. The primary endpoint is a quantitative troponin level at 18-24 hours after PCI. At an enrollment of a total of 150 patients (75 per group), the study is powered to detect a 30% difference in troponin level. Secondary endpoints include elevation of creatine kinase (CK) and CK-MB above the upper limit of normal, change in C-reactive protein (CRP) levels from baseline and thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade. All patients will be started on statin therapy the day after the procedure, as deemed appropriate by their treating physicians.

Conditions

Coronary Disease

Keywords

Acute coronary syndrome; Percutaneous coronary intervention; Peri-procedure myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Peri-procedural Myonecrosis

  As measured by troponin T (TnT), during percutaneous coronary intervention (PCI). TnT will be measured at 18-24 hours. Assuming a 40% event rate (elevation in TnT), this study powered to predict 30% relative reduction in TnT

  24 hours

Secondary Outcomes (3)

• Other Biomarkers of Myocyte Injury (CK, CK-MB)

  24 hours

• Inflammatory Markers (CRP)

  24 hours

• Post PCI Growth of Tissue Level Perfusion Circumference and Brightness Using Digital Subtraction Angiography

  24 hours

Study Arms (3)

atorvastatin 80 mg

ACTIVE COMPARATOR

80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS

Drug: Atorvastatin 80mg; Other: Screening

placebo oral tablet

PLACEBO COMPARATOR

placebo on average of 2-4 hours pre angio/PCI for ACS

Drug: Placebo Oral Tablet; Other: Screening

Screening

NO INTERVENTION

Patients signed consent if willing to participate. Patients will continue onto randomization if appropriate per inc/exc (i.e. stent placement) otherwise screen fail

Interventions

Placebo Oral Tablet DRUG

placebo pre-PCI for ACS

placebo oral tablet

Atorvastatin 80mg DRUG

atorvastatin 80 mg pre-angio/PCI

Also known as: lipitor

atorvastatin 80 mg

Screening OTHER

Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)

atorvastatin 80 mg; placebo oral tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be aged 18 or over.
• Patients must provide written informed consent.
• Patients are presenting with unstable angina (defined as new onset chest pain, accelerating chest pain, chest pain at rest and ST-segment depression on the electrocardiogram \[EKG\])
• Patients undergoing successful coronary stent implantation of the (presumed) culprit lesion (defined as \< 50% residual stenosis).

You may not qualify if:

• Any patient who is unable to give written informed consent.
• Any condition which, in the investigator's opinion, would interfere with optimal participation in the study or produce a significant risk to the patient.
• Patients presenting with an ST-elevation myocardial infarction (MI).
• Patients with elevated troponin, CK, or CK-MB (above the upper limit of normal).
• Patients already on high-dose statin therapy (defined as any statin equivalent to atorvastatin ≥ 40 mg).
• Patients who took any statin agent within 24 hours of presentation to the cardiac catheterization laboratory.
• Patients with active hepatic disease or myositis, in whom statin therapy is contraindicated.
• Patients with hypersensitivity to atorvastatin.
• Patients with procedural complications, including unsuccessful percutaneous transluminal coronary angioplasty (PTCA)/stenting, major side-branch occlusion, flow-limiting dissections at the completion of the procedure, emergent coronary artery bypass surgery, peri-procedural thrombus formation with distal embolization, stent thrombosis within the first 24 hours, repeat emergent PCI within 24 hours, and death within 24 hours.
• Cardiogenic shock.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Pfizer: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Coronary Disease; Acute Coronary Syndrome

Interventions

Atorvastatin; Mass Screening

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: BIDMC

dcutlip@bidmc.harvard.edu

6176678800

Study Officials

• Joseph Carrozza, Jr, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized trial of 80 mg atorvastatin vs. placebo pre PCI

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: June 26, 2006
• Study Start: May 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: January 1, 2009
• Last Updated: January 2, 2018
• Results First Posted: July 2, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)