ROsuvastatin LOading and Clinical Outcomes Trial | NCT01936805

Studies
ROsuvastatin LOading and Clinical Outcomes Trial

NCT01936805

Sponsor

Yuksek Ihtisas Hospital

Status

Completed

Last Update Posted

Sep 6, 2013Estimated

Enrollment

299Actual

Phase

Phase 3

Conditions

Atherosclerosis

Interventions

Rosuvastatin

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Aug 9, 2013

First Submission Date that Met QC Criteria

Sep 2, 2013

First Posted Date

Sep 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2013

Last Update Posted Date

Sep 6, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

299Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug	A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.	Rosuvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke		4 year

Secondary Outcomes

Measure	Description	Time Frame
all cause death		4 year
composite of death or myocardial infarction from CV causes, TVR, or stroke		4 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yuksek Ihtisas Hospital		Ankara	Altindag	06100	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided