NCT01187992

Brief Summary

This study was designed to test the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
Last Updated

August 25, 2010

Status Verified

May 1, 2010

Enrollment Period

3.5 years

First QC Date

August 24, 2010

Last Update Submit

August 24, 2010

Conditions

Acute Coronary SyndromeCoronary Artery Disease

Keywords

AtorvastatinAcute coronary syndromeAdvanced coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

    The primary end point of the study was prospectively defined as the combination of cardiovascular death, non-fatal acute myocardial re-infarction (re-AMI) and disabling non-fatal stroke.

    12 months

Secondary Outcomes (5)

  • Cardiovascular mortality

    12 months

  • Non-fatal acute myocardial re-infarction (re-AMI)

    12 months

  • Disabling non-fatal stroke

    12 months

  • New-onset heart failure

    12 months

  • Atrial fibrillation

    12 months

Study Arms (2)

Full-dose atorovastatin (80 mg/d)

EXPERIMENTAL

For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation.

Drug: Atorvastatin

Conventional medical treatment

NO INTERVENTION

For patients randomised to this arm, adherence to the National Cholesterol Education Program, Adult Treatment Panel III guidelines was required. In particular, in these patients,atorvastatin was started at the initial dosage of 20 mg/day immediately after randomisation. Subsequently, atorvastatin dosage was titrated in order to attain low-density lipoprotein cholesterol (LDL-C) levels \<100 mg/dL (2.5 mmol/L).

Interventions

AtorvastatinDRUG

80 mg/day

Full-dose atorovastatin (80 mg/d)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-ST-segment elevation acute myocardial infarction.
  • coronary angiography within 48 hours from admission.
  • angiographic evidence of severe and diffuse coronary artery disease,not amenable to conventional direct revascularisation techniques by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI).

You may not qualify if:

  • ST-segment elevation acute myocardial infarction,
  • clinical history of heart failure
  • left ventricular ejection fraction \<35%,
  • any form of severe valvular dysfunction,
  • previous implantation or indication to implant a cardioverter-defibrillator during the index admission,
  • any increase in liver enzymes,
  • history of any liver or muscle disease,
  • renal failure with serum creatinine \>2.5 mg/dL (221 mmol/L),
  • need for continued use of intravenous medications to relieve anginal symptoms,
  • presence of any major comorbidity with life expectancy \<24 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Filippo Neri General Hospital

Rome, Italy, I-00135, Italy

Location

Related Publications (1)

  • Colivicchi F, Tubaro M, Mocini D, Genovesi Ebert A, Strano S, Melina G, Uguccioni M, Santini M. Full-dose atorvastatin versus conventional medical therapy after non-ST-elevation acute myocardial infarction in patients with advanced non-revascularisable coronary artery disease. Curr Med Res Opin. 2010 Jun;26(6):1277-84. doi: 10.1185/03007991003751496.

    PMID: 20367555RESULT

MeSH Terms

Conditions

Acute Coronary SyndromeCoronary Artery Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Furio Colivicchi, MD

    Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 25, 2010

Study Start

September 1, 2003

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

August 25, 2010

Record last verified: 2010-05

Locations

IT(1)