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临床试验/NCT05831462
NCT05831462尚未招募1 期

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

Assiut University0 个研究点目标入组 400 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
400
主要终点
primary efficacy endpoint, primary safety endpoint

研究概览

简要总结

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

详细描述

[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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetes Mellitus. Acute STEMI. Able to swallow tablets.

排除标准

  • Patients presenting with stent thrombosis. Hypersensitivity to ticagrelor and/or aspirin. Active bleeding. ARC-high bleeding risk status
  • 2nd or 3rd degree AV block. Previous stent thrombosis on treatment with ticagrelor. Pregnancy or lactation.

研究组 & 干预措施

Standard dose ticagrelor with aspirin in patients post PPCI for 1 year.

Active Comparator

Drug: Ticagrelor 90 mg until 1 year after PPCI (other name: Brillique). Drug: Aspirin 75 mg until 1 year after PPCI.

干预措施: Ticagrelor 60mg (Drug)

Low-dose Ticagrelor with aspirin in patients post PPCI

Experimental

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.

干预措施: Ticagrelor 60mg (Drug)

结局指标

主要结局

primary efficacy endpoint, primary safety endpoint

时间窗: after 12 months

including CV death, non-fatal MI, non-fatal stroke, coronary revascularization barc 2,3,5 bleeding

次要结局

  • secondry endpoints(after 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Taha Galal

Cardiology specialist at assiut university hospital

Assiut University

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