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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02808039
Other study ID # RMC 2016-3
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 17, 2016
Last updated June 17, 2016
Start date September 2016

Study information

Verified date June 2016
Source Rabin Medical Center
Contact Guy Witberg, MD
Phone (+972)528478828
Email vitberguy@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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 .

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
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)

Locations

Country Name City State
Israel Rabin Medical Center - Hsharon Campus Petach-Tikva

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary platelet reactivity from 1 week prior to 12 weeks post DAPT cessation No
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