NCT02808039

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

June 17, 2016

Last Update Submit

June 17, 2016

Conditions

Dual Antiplatelet TherapyPlatelet Reactivity

Outcome Measures

Primary Outcomes (1)

  • platelet reactivity

    from 1 week prior to 12 weeks post DAPT cessation

Study Arms (1)

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.

Other: Platelet reactivity testing

Interventions

Platelet reactivity testingOTHER

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

DAPT patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent coronary stent implantation and completed 12 months of DAPT regimen with Ticagrelor with no clinical or adverse events.

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center - Hsharon Campus

Petah Tikva, 49100, Israel

Location

Study Officials

  • Guy Witberg, MD

    Rabin Medical Center, Department of Cardiology

    PRINCIPAL INVESTIGATOR

  • Eli Lev, MD

    Rabin Medical Center, Department of Cardiology

    STUDY DIRECTOR

Central Study Contacts

Guy Witberg, MD

CONTACT

(+972)528478828vitberguy@gmail.com

Eli Lev, MD

CONTACT

(+972)504065490elev@tmhs.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Guy Witberg, MD department of cardiology , Rabin medical centre

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Last Updated

June 21, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Locations

IL(1)