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临床试验/CTRI/2023/10/059339
CTRI/2023/10/059339尚未招募不适用

To evaluate the safety and efficacy of antiplatelet strategies in patients undergoing percutaneous coronary intervention with drug-eluting stents: A Prospective Observational Study

Pragya Hangma Subba1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2023年10月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
146
试验地点
1
主要终点
The primary endpoint is Net Adverse Clinical Events ( NACE ) within 3-6 months of percutaneous coronary intervention, which includes major adverse cardiac and cerebrovascular events (MACCE) plus major bleeding includes the composite of all-cause death, myocardial infarction, stent thrombosis, stroke, and target vessel revascularization.

研究概览

简要总结

According to the World Health Organization (WHO), CVD is the leading cause of death worldwide, accounting for an estimated 17.9 million deaths each year. This represents about 31% of all deaths worldwide.Although substantial progress has been made in the diagnosis and treatment of acute coronary syndromes (ACS), cardiovascular disease remains the leading cause of death worldwide, with nearly half of these deaths due to ischaemic heart disease.Effective secondary prevention after ACS involves prompt recognition of symptoms, early hospitalization, and initiation of appropriate medical therapy. Revascularization, antiplatelet therapy, lipid-lowering therapy, and blood pressure control are all important components of ACS management. Antiplatelet therapy represents the cornerstone treatment and secondary prevention of CAD. Compared with placebo, antiplatelet therapy has been shown to reduce recurrent major adverse cardiovascular events (MACE) among patients with stable CAD or ACS, however, it is inevitably associated with increased bleeding.Patients with ACS undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) are currently recommended dual antiplatelet therapy (DAPT), consisting of aspirin with P2Y12 receptor inhibitors to prevent thrombotic complications such as stent thrombosis. Patients receive DAPT for 6-12 months after DES implantation. The efficacy and safety of prolonged DAPT have been questioned. Compared to less than 12 months of DAPT, 12 months of DAPT did not reduce the risk of myocardial infarction, stent thrombosis, strokes, or cardiac or all-cause mortality, but increased the risk of major bleeds.DAPT beyond 12 months reduces the risk of myocardial infarction and stent thrombosis, but there is a substantial increase in major bleeding risk and all-cause mortality which need to be addressed. DAPT with aspirin and a P2Y12 inhibitor is recommended following an acute coronary syndrome (ACS) to help prevent further thromboembolic events.There are three commercially available oral P2Y12 inhibitors; clopidogrel, prasugrel, and ticagrelor. Clopidogrel is the most commonly used agent, likely due to its cost-effectiveness compared to the other two agents. However, clinical trials have shown that both prasugrel and ticagrelor are associated with lower rates of CV death, MI, or stroke when compared to clopidogrel in the management of ACS .Safety concerns exist surrounding the appropriate strategy for switching between oral P2Y12 inhibitors. Due to the pharmacological and pharmacokinetic differences between oral P2Y12 inhibitors, including half-life, site of action, mechanism, and onset of action, there may be concern that switching between agents could lead to a period of inadequate platelet inhibition and further thromboembolic events. In contrast, there may be concern that a period of more robust platelet inhibition could occur while switching between agents, raising the risk of potential bleeding.Guidance on the best modality for switching between these agents had been lacking, particularly regarding timing and the need for reloading. This study aims to evaluate the safety and efficacy of different antithrombotic strategies, particularly for switching between oral P2Y12 inhibitors at our institution, and compare our findings to the most recently published expert consensus recommendations.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients above 18 years of age have documented administration of at least two different oral DAPT after PCI with DES implantation.

排除标准

  • Patients with active bleeding or bleeding disorder
  • Patients with contraindications to antiplatelet therapy
  • Patients with ongoing long-term treatment with oral anticoagulants.

结局指标

主要结局

The primary endpoint is Net Adverse Clinical Events ( NACE ) within 3-6 months of percutaneous coronary intervention, which includes major adverse cardiac and cerebrovascular events (MACCE) plus major bleeding includes the composite of all-cause death, myocardial infarction, stent thrombosis, stroke, and target vessel revascularization.

时间窗: 3-6 months after percutaneous coronary intervention.

次要结局

  • Secondary endpoints included each component of the primary endpoint.(The incidence of the primary outcome of MACE observed when switching to an alternative oral P2Y12 inhibitor.)

研究者

发起方
Pragya Hangma Subba
申办方类型
Other [self]

研究点 (1)

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