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Trial record 61 of 1302 for:    ASPIRIN AND Platelet Aggregation

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

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Platelet Function and Reactivity Tests Novel P2Y12 Inhibitors Drug: Aspirin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Aspirin Impact on Platelet Reactivity in Acute Coronary Syndrome Patients on Novel P2Y12 Inhibitors Therapy
Study Start Date : June 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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.




Primary Outcome Measures :
  1. Platelet reactivity [ Time Frame: one month ]
    platelet reactivity in response to arachidonic acid


Secondary Outcome Measures :
  1. platelet reactivity [ Time Frame: one month ]
    platelet reactivity in response to ADP


Other Outcome Measures:
  1. clinical outcome [ Time Frame: two months ]
    hospitalizations and mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049762


Locations
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Israel
Sheba Medical Center
Tel-Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Shlomi Matezky Sheba Medical Center

Publications:

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Responsible Party: Dr. Shlomi Matetzky, Head of The Cardiac Intensive Care Unit, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02049762     History of Changes
Other Study ID Numbers: 0813-13-SMC
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Shlomi Matetzky, Sheba Medical Center:
novel P2Y12 inhibitors
aspirin
platelet reactivity
acute coronary syndrome
Additional relevant MeSH terms:
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Aspirin
Platelet Aggregation Inhibitors
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics