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

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ClinicalTrials.gov Identifier: NCT02049762
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Shlomi Matetzky, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE January 28, 2014
First Posted Date  ICMJE January 30, 2014
Last Update Posted Date February 21, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2014)
Platelet reactivity [ Time Frame: one month ]
platelet reactivity in response to arachidonic acid
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02049762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2014)
platelet reactivity [ Time Frame: one month ]
platelet reactivity in response to ADP
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 29, 2014)
clinical outcome [ Time Frame: two months ]
hospitalizations and mortality
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Aspirin Impact on Platelet Reactivity in Acute Coronary Syndrome Patients on Novel P2Y12 Inhibitors Therapy
Official Title  ICMJE Aspirin Impact on Platelet Reactivity in Acute Coronary Syndrome Patients on Novel P2Y12 Inhibitors Therapy
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Acute Coronary Syndrome
  • Platelet Function and Reactivity Tests
  • Novel P2Y12 Inhibitors
Intervention  ICMJE Drug: Aspirin
Aspirin 100 mg vs. placebo in ACS patients on P2Y12 inhibitors a month following PCI.
Study Arms  ICMJE
  • Active Comparator: P2Y12 inhibitors and aspirin
    ACS patients on novel P2Y12 inhibitors and aspirin
    Intervention: Drug: Aspirin
  • Placebo Comparator: P2Y12 inhibitors and placebo
    ACS patients on novel P2Y12 inhibitors and placebo
    Intervention: Drug: Aspirin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2018)
29
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2014)
70
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02049762
Other Study ID Numbers  ICMJE 0813-13-SMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Shlomi Matetzky, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shlomi Matezky Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP