NCT01936805

Brief Summary

The aim of the present study was to evaluate the effect of pre-procedural single high loading dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and composite of death or myocardial infarction from cardiovascular (CV) causes, target vessel revascularization (TVR), or stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
299

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2008

Typical duration for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
Last Updated

September 6, 2013

Status Verified

September 1, 2013

Enrollment Period

4 years

First QC Date

August 9, 2013

Last Update Submit

September 2, 2013

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke

    4 year

Secondary Outcomes (2)

  • all cause death

    4 year

  • composite of death or myocardial infarction from CV causes, TVR, or stroke

    4 year

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR

A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.

Drug: Rosuvastatin

Control

PLACEBO COMPARATOR

A loading dose of placebo was administrated 24 h before the PCI.

Interventions

RosuvastatinDRUG

A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.

Rosuvastatin

Eligibility Criteria

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

You may qualify if:

  • statin-naive patients
  • stable ischemic heart disease
  • de novo lesions appropriate for PCI

You may not qualify if:

  • current statin use
  • statin allergic patients
  • acute coronary syndromes
  • lesions not appropriate for PCI
  • refusal for participation
  • statin quitting during follow- up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtisas Hospital

Ankara, Altindag, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 9, 2013

First Posted

September 6, 2013

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 6, 2013

Record last verified: 2013-09

Locations

TU(1)