De-escalation of Ticagrelor in Post PPCI

April 25, 2023 updated by: Mohamed Taha Galal, Assiut University

Standard Versus Low Dose Maintenance Ticagrelor After Primary Percutaneous Intervention for STEMI in Diabetic Patients: a Randomized Controlled Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

[15:42, 18/02/2023] M Taha: Ticagrelor at a maintenance dose of 90 mg twice a day (bid) was shown to provide greater and more consistent platelet P2Y12 inhibition than clopidogrel in patients with stable coronary artery disease (PA Gurbal, KP Bliden et al 2009) and acute coronary syndromes (ACS) (RF Storey, S Husted et al 2007).

The PLATO (Platelet Inhibition and Patient Outcomes) trial demonstrated the superior efficacy of ticagrelor, given at a maintenance dose of 90 mg bid, compared with clopidogrel for up to 1 year in patients with ACS (L Wallentin, RC Becker et al 2009) [15:42, 18/02/2023] M Taha: Consequently, this regimen of ticagrelor is recommended in international guidelines as first-line therapy for up to 1 year following either non-ST-segment elevation ACS (P Damman, AW van't Hof et al 2017) or ST-segment elevation myocardial infarction managed with primary percutaneous coronary intervention (PT O'gara, FG Kushner et al 2013).

In the PEGASUS-TIMI 54 trial, ticagrelor maintenance doses of 60 mg b.i.d and 90 mg b.i.d were clinically equally effective in stable patients more than 1 year after acute myocardial infarction (AMI), with a better tolerability of treatment observed with the lower dose (Bonaca MP, Bhatt DL et al 2016).

[15:42, 18/02/2023] M Taha: n a pharmacokinetic & pharmacodynamic substudy of the PEGASUS-TIMI 54 trial, ticagrelor 60 mg bid achieved high levels of peak and trough platelet inhibition in nearly all patients, similar to that with 90 mg bid, helping to explain the efficacy of the lower ticagrelor dose in the trial.1 Most recently, in a pharmacodynamic randomized controlled study (ELECTRA), lowering ticagrelor maintenance dose to 60 mg b.i.d, on day 30 following acute MI, was shown to confer an adequate antiplatelet effect that is comparable to the standard maintenance dose of 90 mg b.i.d.2

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Diabetes Mellitus. Acute STEMI. Able to swallow tablets.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard dose ticagrelor with aspirin in patients post PPCI for 1 year.
Drug: Ticagrelor 90 mg until 1 year after PPCI (other name: Brillique). Drug: Aspirin 75 mg until 1 year after PPCI.
Drug: Ticagrelor 60mg
Standard vs Low dose ticagrelor in post PPCI patients
Other Names:
  • Brillique
Experimental: Low-dose Ticagrelor with aspirin in patients post PPCI

Patients 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.
Drug: Ticagrelor 60mg
Standard vs Low dose ticagrelor in post PPCI patients
Other Names:
  • Brillique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary efficacy endpoint, primary safety endpoint
Time Frame: after 12 months
including CV death, non-fatal MI, non-fatal stroke, coronary revascularization barc 2,3,5 bleeding
after 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
secondry endpoints
Time Frame: after 12 months
dyspnea leading to discontinuation of ticagrelor, barc 1 bleeding leading to discontinuation of the drug
after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ticagrelor in post PPCI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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