Antiplatelet Effect of Low Doses of Aspirin Taken Every 1... | NCT01466452

Status Module

Record Verification Date

Nov 2011

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

Sep 2011

Primary Completion Date

Sep 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Oct 20, 2011

First Submission Date that Met QC Criteria

Nov 7, 2011

First Posted Date

Nov 8, 2011Estimated

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

Nov 7, 2011

Last Update Posted Date

Nov 8, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alessandro Parolari, Assistant Professor of Cardiac Surgery, Centro Cardiologico MonzinoPrincipal Investigator

Lead Sponsor

Centro Cardiologico MonzinoOTHER

Collaborators

Name	Class
Catholic University, Italy	OTHER
University of Chieti	OTHER

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

This study is a randomized open label study that implies the administration of asprin according to three different regimens.

The aims of the study are:

to establish whether coronary artery bypass surgery and / or aortic valve replacement surgery with bioprostheses is associated with changes in the rate of platelet regeneration that can reduce the effectiveness of aspirin administered at a dose of 100mg/die in terms of inhibition of platelet biosynthesis of thromboxane A2.
to determine whether these patients need a different (shorter) interval of administration in order to completely and permanently inhibit the platelet COX-1.

The endpoints of this study are:

- To evaluate the changes in the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after administration of aspirin and the changes in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2 alpha urinary, 2-3 dinor-6-chetoPGF1 alpha, Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

99Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Aspirin 100	Active Comparator	Drug: Aspirin
Aspirin 200	Active Comparator	Drug: Aspirin
Aspirin 100 x 2	Active Comparator	Drug: Aspirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspirin	Drug	single-dose aspirin in 100 mg 1 tablet every 24 hours	Aspirin 100

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin		one year
change in the levels of 12-HETE in serum at 12 and 24 hours after administration of aspirin		one year

Secondary Outcomes

Measure	Description	Time Frame
change in the levels of 11-dehydro TXB2 urinary at 12 and 24 hours after administration of aspirin		one year
change in the levels of 8-iso-PGF2 alpha urinary at 12 and 24 hours after administration of aspirin		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed consent of the study signed
coronary artery bypass graft and / or aortic valve replacement surgery with bioprostheses
age between 55 and 80
ejection fraction > 30%.

Exclusion Criteria:

excessive bleeding (> 1000mL / 6 h) or the need of re operation for bleeding
perioperative myocardial infarction
stroke or renal failure requiring dialysis and need waiting for post-operative anticoagulation
patients undergoing coronary artery bypass grafting procedure as a consequence of failed percutaneous coronary intervention
patients undergoing off-pump coronary artery bypass graft
overt kidney or liver disease
therapies that influence the coagulation
fertile women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alessandro Parolari, MD PhD	Contact	+39 025800	2355	alessandro.parolari@ccfm.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Cardiologico Monzino, IRCCS	Recruiting	Milan	Milano	20138	Italy

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals