NCT01306565

Brief Summary

The aim of this study is to compare the effect of high dose and low dose of Atorvastatin in reduction level of C-reactive protein (CRP) in patients with unstable angina and NSTEMI (Non ST Elevation MI) attending Shahid Mohammadi hospital in Bandar Abbas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
Last Updated

March 2, 2011

Status Verified

November 1, 2008

Enrollment Period

1.4 years

First QC Date

March 1, 2011

Last Update Submit

March 1, 2011

Conditions

Cardiovascular Disease

Keywords

Unstable anginaNSTMIStatinAtorvastatin

Outcome Measures

Primary Outcomes (1)

  • CRP reduction

    CRP reduction will be compared between two study groups

    72 hours

Secondary Outcomes (1)

  • Drug side effects

    72 hours

Study Arms (2)

High dose atorvastatin

ACTIVE COMPARATOR

Three 80mg daily doses of atorvastatin

Drug: Low dose Atorvastatin

Low dose Atorvastatin

EXPERIMENTAL

80mg atorvastatin followed by two 20mg daily atorvastatin

Drug: High dose atorvastatin

Interventions

Low dose AtorvastatinDRUG

80mg atorvastatin followed by two 20mg daily atorvastatin

Also known as: Lipitor
High dose atorvastatin
High dose atorvastatinDRUG

80mg daily atorvastatin for 72 hours

Also known as: Lipitor
Low dose Atorvastatin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with unstable angina with chest discomfort at rest with normal EKG or St depression (at least 0.1mv) in two consecutive leads or new and deep T inversion (at least 0.2mv)

You may not qualify if:

  • Myocardial Infarction with ST elevation
  • Diabetes Mellitus
  • Previous statin use
  • Current infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, 097145-3388, Iran

Location

MeSH Terms

Conditions

Cardiovascular DiseasesAngina, Unstable

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Vahid Vahdatkhah

    Hormozgan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 2, 2011

Study Start

January 1, 2009

Primary Completion

June 1, 2010

Study Completion

January 1, 2011

Last Updated

March 2, 2011

Record last verified: 2008-11

Locations

IR(1)