De-escalation of Ticagrelor in Post PPCI

NCT ID: NCT05831462

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-05-01

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

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

Conditions

Ticagrelor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ticagrelor 60mg

Intervention Type: DRUG

Standard vs Low dose ticagrelor in post PPCI patients

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.

Group Type: EXPERIMENTAL

Ticagrelor 60mg

Intervention Type: DRUG

Standard vs Low dose ticagrelor in post PPCI patients

Interventions

Ticagrelor 60mg

Standard vs Low dose ticagrelor in post PPCI patients

Intervention Type: DRUG

Other Intervention Names

Brillique

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Taha Galal

Cardiology specialist at assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Taha Galal, MSc cardiology

Role: CONTACT

mohamedtahagalal90@gmail.com

+10269050

Amr Elbadry, PHD cardiology

Role: CONTACT

amr_el_badry@hotmail.com

01060701601

Related Links

http://journals.viamedica.pl/cardiology_journal/article/view/84307

Related Info

Other Identifiers

Ticagrelor in post PPCI

Identifier Type: -

Identifier Source: org_study_id