NCT00657527

Brief Summary

The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2001

Shorter than P25 for phase_3

Status
completed

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

December 1, 2001

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

First QC Date

April 8, 2008

Last Update Submit

March 13, 2009

Conditions

Myocardial IschaemiaCoronary Artery Disease

Keywords

CrestorRosuvastatinCholesterolCoronary artery diseaseMyocardial ischaemia.

Outcome Measures

Primary Outcomes (1)

  • Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.

    8 weekly

Secondary Outcomes (3)

  • Change in duration of ischemic episodes

    8 weekly

  • Safety

    8 weekly

  • Several laboratory parameters as detailed in the protocol

    8 weekly

Study Arms (2)

1

EXPERIMENTAL

Rosuvastatin

Drug: Rosuvastatin

2

NO INTERVENTION

Diet

Behavioral: Cholesterol lowering diet

Interventions

RosuvastatinDRUG
Also known as: Crestor
1
Cholesterol lowering dietBEHAVIORAL
2

Eligibility Criteria

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

You may qualify if:

  • Evidence of Coronary arterial disease
  • Suffering ischaemic episodes/exercise induced ischaemia
  • Not taking any cholesterol lowering medication

You may not qualify if:

  • Unstable angina or heart attack less than one month before trial entry
  • Coronary arterial surgery as defined by protocol
  • Uncontrolled hypertension, diabetes, hypothyroidism or laboratory values as defined by the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael Cressman, DO

    AstraZeneca

    STUDY DIRECTOR

  • Russell Esterline

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 14, 2008

Study Start

December 1, 2001

Study Completion

December 1, 2002

Last Updated

March 16, 2009

Record last verified: 2009-03