Aspirin Impact on Platelet Reactivity in Acute Coronary Syndrome Patients on Novel P2Y12 Inhibitors Therapy

February 19, 2018 updated by: Dr. Shlomi Matetzky, Sheba Medical Center

Thus far, no study has evaluated the impact on aspirin in addition to the newer and more potent P2Y12 inhibitors, among ACS patients and current guidelines recommend dual anti-platelet therapy consisting of aspirin and a novel P2Y12 inhibitor in this population.

Objective The investigators goal is to examine the effect of aspirin in addition to new anti-platelet agent (ticagrelor\prasugrel) on platelet reactivity in comparison with placebo, among ACS patients treated percutaneously.

Design The proposed study is a randomized-controlled, double blind trial, conducted among ACS patients treated percutaneously. Eligible patients will recruited during hospitalization due to ACS after percutaneous coronary intervention (PCI), and randomization by envelopes on 1:1 basis will take place a month after the index event, at a follow-up visit at the cardiac clinic.

Platelet function and Endothelial function tests will be taken a month after the index event, and at a 2 weeks periods following aspirin/placebo therapy, cross-over and return to open-label aspirin.

End-points platelet function tests will be compared between aspirin and placebo therapy and before and after the cross-over.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Current knowledge and data support the use of dual anti-platelets for patients after acute coronary syndrome (ACS). Novel P2Y12 inhibitors have shown their superiority on clopidogrel in regarding morbidity and mortality, but at the cost of higher bleeding rates - even in lower doses of aspirin there is increase risk for gastrointestinal (GI) bleeding. In a geographical analysis of the PLATO trial it has been shown difference at outcome. When higher dose of aspirin were used, the superiority of ticagrelor was reduced.

The use of platelet reactivity tests have been proved and acknowledged in their usefulness for gauging bleeding and ischemic risks. Few studies have shown that clopidogral is inhibiting not only the ADP activity, but also the arachidonic acid (AA) pathway that is considered aspirin specific pathway. Examining the effect of potent P2Y12 inhibitors in healthy volunteers have shown increased inhibition of the AA pathway. Not only that the adding of aspirin, have shown little effect on inhibition of AA pathway.

It has been demonstrated that vascular endothelial function is inversely correlated to platelet reactivity in both individuals without established cardiovascular disease (controls) and acute myocardial infarction patients.

Objective Our goal is to examine the effect (platelet function test and endothelial function) of aspirin while added to novel P2Y12 inhibitors treated ACS patients.

Design The proposed study is a randomized-controlled, double blind trial, conducted among ACS patients treated percutaneously. Eligible patients will recruited during hospitalization due to ACS after percutaneous coronary intervention (PCI), and randomization by envelopes on 1:1 basis will take place a month after the index event, at a follow-up visit at the cardiac clinic.

Platelet function and Endothelial function tests will be taken a month after the index event, and at a 2 weeks periods following aspirin/placebo therapy, cross-over and return to open-label aspirin.

Study end-points The primary end-point is platelet function tests in response to AA. Secondary end-points will include endothelial function and platelet reactivity according to the platelet activity and VerifyNow test in response to ADP and platelet activation Clinical outcomes including all-cause and cardiac mortality and hospitalizations, recurrent ischemia and stent thrombosis, and bleeding events along with blood transfusions, will be recorded as safety end-points.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Hashomer, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age>18 years
  • ACS defined according to the 3rd universal definition of MI
  • PCI therapy

Exclusion Criteria:

  • Indication for anticoagulant therapy
  • ACS on new P2Y12 inhibitors treatment
  • Contraindication to P2Y12 therapy
  • Renal failure defined as creatinine ≥1.5 mg/dL
  • Non-compliance
  • Life-threatening extra-cardiac disease or malignancy with a life expectancy below 1 year
  • Inability to sign an informed consent
  • Participation in another trial during the previous 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: P2Y12 inhibitors and aspirin
ACS patients on novel P2Y12 inhibitors and aspirin
Drug: Aspirin
Aspirin 100 mg vs. placebo in ACS patients on P2Y12 inhibitors a month following PCI.
Placebo Comparator: P2Y12 inhibitors and placebo
ACS patients on novel P2Y12 inhibitors and placebo
Drug: Aspirin
Aspirin 100 mg vs. placebo in ACS patients on P2Y12 inhibitors a month following PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet reactivity
Time Frame: one month
platelet reactivity in response to arachidonic acid
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
platelet reactivity
Time Frame: one month
platelet reactivity in response to ADP
one month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcome
Time Frame: two months
hospitalizations and mortality
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Shlomi Matezky, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 19, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0813-13-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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