De-escalation of Ticagrelor in Post PPCI
Standard Versus Low Dose Maintenance Ticagrelor After Primary Percutaneous Intervention for STEMI in Diabetic Patients: a Randomized Controlled Trial
1 other identifier
interventional
400
0 countries
N/A
Brief Summary
Primary objective: to evaluate the efficacy and safety of De-escalation to lower dose Ticagrelor (60 mg BID) plus Aspirin (75 mg OD) versus continuation of standard dose Ticagrelor (90 mg BID) plus Aspirin (75 mg OD), 1 month after primary PCI for STEMI, in diabetic patients. Secondary objectives: To compare tolerability and discontinuation of Ticagrelor in both doses. To compare the 1ry safety \& efficacy endpoints in subgroups with different thrombotic/ischemic risk
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedApril 26, 2023
April 1, 2023
10 months
February 18, 2023
April 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
primary efficacy endpoint, primary safety endpoint
including CV death, non-fatal MI, non-fatal stroke, coronary revascularization barc 2,3,5 bleeding
after 12 months
Secondary Outcomes (1)
secondry endpoints
after 12 months
Study Arms (2)
Standard dose ticagrelor with aspirin in patients post PPCI for 1 year.
ACTIVE COMPARATORDrug: Ticagrelor 90 mg until 1 year after PPCI (other name: Brillique). Drug: Aspirin 75 mg until 1 year after PPCI.
Low-dose Ticagrelor with aspirin in patients post PPCI
EXPERIMENTALPatients will recieve the following antiplatlet therapy: 1. Ticagrelor 2x90 mg + aspirin 1x 75 during the first three months post PPCI. 2. Ticagrelor 2x60 mg + aspirin 1x 75 after the first three months post PPCI until one year post PPCI.
Interventions
Standard vs Low dose ticagrelor in post PPCI patients
Eligibility Criteria
You may qualify if:
- Diabetes Mellitus. Acute STEMI. Able to swallow tablets.
You may not qualify if:
- Patients presenting with stent thrombosis. Hypersensitivity to ticagrelor and/or aspirin. Active bleeding. ARC-high bleeding risk status1. 2nd or 3rd degree AV block. Previous stent thrombosis on treatment with ticagrelor. Pregnancy or lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiology specialist at assiut university hospital
Study Record Dates
First Submitted
February 18, 2023
First Posted
April 26, 2023
Study Start
June 1, 2023
Primary Completion
March 31, 2024
Study Completion
May 1, 2024
Last Updated
April 26, 2023
Record last verified: 2023-04