Is There a Transient Rebound Effect of Platelet Reactivity Following Cessation of Dual Antiplatelet Therapy With Ticagrelor - a Single Center Prospective Observational Trial

NCT ID: NCT02808039

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Brief Summary

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to assess whether cessation of 12 months DAPT regimen containing Ticagrelor results in a hyperreactive phase of platelet function

Detailed Description

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the study will be composed of a cohort of patients , who completed 12 months of DAPT with Ticagrelor (standard recommended dose for ACS - 90 mg BID), did not experience any clinical or adverse event during this time period and are about to discontinue Ticagrelor. We intend to measure the platelet reactivity for each patient on 4 time points - prior to cessation of Ticagrelor (i.e. while still on DAPT) and 1,4 and 12 weeks post discontinuation of therapy. There will not be a control group.

Conditions

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Dual Antiplatelet Therapy Platelet Reactivity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DAPT patients

Patients planned for cessation of DAPT regimen containing Ticagrelor after 12 months of treatment following coronary stent implantation . the platelet reactivity will be assessed 1 week prior to cessation of DAPT and than at 1,3,and 12 weeks post DAPT cessation.

Platelet reactivity testing

Intervention Type OTHER

assessment of platelet aggregation using the VerifyNow purinergic receptor P2Y, G-protein coupled, 12 (P2Y12) platelet function assay (Accumetrics, San Diego, California)

Interventions

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Platelet reactivity testing

assessment of platelet aggregation using the VerifyNow purinergic receptor P2Y, G-protein coupled, 12 (P2Y12) platelet function assay (Accumetrics, San Diego, California)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age\>18
* underwent coronary stent implantation due to ACS
* completed 12 month of DAPT regimen containing Ticagrelor at standard dose (90 mg BID)

Exclusion Criteria

* any ischemic or bleeding events while under Ticagrelor
* any other Ticagrelor associated adverse effects
* planned for continuation of Ticagrelor for more than 12months post stenting according to the judgment of the attending physician.
* Unable to make informed consent .
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Guy Witberg

Dr Guy Witberg, MD department of cardiology , Rabin medical centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guy Witberg, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center, Department of Cardiology

Eli Lev, MD

Role: STUDY_DIRECTOR

Rabin Medical Center, Department of Cardiology

Locations

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Rabin Medical Center - Hsharon Campus

Petah Tikva, , Israel

Site Status

Countries

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Israel

Central Contacts

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Guy Witberg, MD

Role: CONTACT

(+972)528478828

Eli Lev, MD

Role: CONTACT

(+972)504065490

Facility Contacts

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Guy Witberg, MD

Role: primary

9+972)528478828

Eli Lev, MD

Role: backup

9+972)504065490

Other Identifiers

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RMC 2016-3

Identifier Type: -

Identifier Source: org_study_id

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