Aspirin Resistance Following Coronary Bypass Surgery | NCT00260377

Studies
Aspirin Resistance Following Coronary Bypass Surgery

NCT00260377

Sponsor

Sheba Medical Center

Status

Terminated

Last Update Posted

Sep 9, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Ischemic Heart Disease

Interventions

Coronary artery bypass surgery

Countries

Israel

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 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The researcher had left the hospital and the project was stopped

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jun 2006

Completion Date

Dec 2006

First Submitted Date

Nov 29, 2005

First Submission Date that Met QC Criteria

Nov 29, 2005

First Posted Date

Dec 1, 2005Estimated

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 8, 2008

Last Update Posted Date

Sep 9, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Aspirin was proved to be the drug preventing vein grafts from closure and improving clinical outcome after coronary artery bypass surgery. It appears to be effective when being prescribed as early as first 48 hr. after the operation without increasing the incidence of bleeding complications. the exact effective dose is not known.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Coronary artery bypass surgery	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ventilation
Inotropic support
Mortality
Perioperative MI
Perioperative stroke
Bleeding / reopen / transfusion
Dysrhythmias

Secondary Outcomes

Measure	Description	Time Frame
ICU stay
In-hospital stay
Non-fatal cardiac events - MI, recurrence of angina, dysrhythmias

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing Coronary artery bypass surgery
Patients who signed Informed Consent Form

Exclusion Criteria:

Concomitant valve surgery or carotid surgery or off-pump surgery
Need for anticoagulation therapy for any reason
Another antiplatelet medications at least 7 days prior to surgery
Contra-indication for aspirin treatment
Thrombocytopenia / thrombocytopathia
NSAIDs treatment for chronic medical conditions
Reluctance to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacob Lavee, Dr	jacob.lavee@sheba.health.gov.il	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Ramat Gan			Israel

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001026	Coronary Artery Bypass

Ancestor Terms

ID	Term
D009204	Myocardial Revascularization
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided