Efficacy and Safety of Aspirin Therapy With CABG | NCT02942680

Studies
Efficacy and Safety of Aspirin Therapy With CABG

NCT02942680

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Status

Unknown status

Last Update Posted

Oct 24, 2016Estimated

Enrollment

350Estimated

Phase

Phase 3

Conditions

Coronary Heart Disease

Interventions

acetylsalicylic acid started for 24 hours before surgery
acetylsalicylic acid stayed for 5 days before surgery

Countries

Russia

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

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jan 2018Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Jan 31, 2016

First Submission Date that Met QC Criteria

Oct 21, 2016

First Posted Date

Oct 24, 2016Estimated

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

Oct 21, 2016

Last Update Posted Date

Oct 24, 2016Estimated

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

evaluate the safety of preoperative aspirin therapy when performing bypass surgery in conditions of artificial blood circulation

Detailed Description

The hypothesis of the study was that aspirin therapy started 24 hours before CABG is safe.

The effectiveness of this hypothesis will be assessed by the presence of a 30-day period after CABG myocardial infarction, ischemic stroke, repeat revascularizations

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

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	acetylsalicylic acid started for 24 hours before surgery and determination of platelet function	Drug: acetylsalicylic acid started for 24 hours before surgery
Control	Other	acetylsalicylic acid stayed for 5 days before surgery and determination of platelet function	Drug: acetylsalicylic acid stayed for 5 days before surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acetylsalicylic acid started for 24 hours before surgery	Drug		Experimental
acetylsalicylic acid stayed for 5 days before surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
on discharge drains after surgery in milliliters		24 hours after surgery

Secondary Outcomes

Measure	Description	Time Frame
myocardial infarction		myocardial infarction by 30th day after procedure
ischemic stroke		stroke by 30th day after procedure
repeat revascularization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years of age or older
Patient able to give informed consent

Exclusion Criteria:

Missing consent
Urgent or emergent surgery
Off-pump CABG
Рatient has clear indication for anticoagulation (eg. mechanical heart valve, atrial fibrillation) or ADP receptor antagonist (eg. drug-eluting stent)
History of bleeding diathesis, significant GI bleed, ICH, or liver failure
Allergy to or intolerance of aspirin

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

Name	Role	Phone	Extension	Email
Aleksey Kurguzov	Contact	+9137011917		Aleksey_kurguzov@mail.ru

Overall Officials

Name	Affiliation	Role
Alexander M. Chernyavskiy, MD PhD	Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meshalkin State Research Institute of Circulation Pathology	Recruiting	Novosibirsk		630055	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided