Ticagrelor Versus Clopidogrel for CMD in Patients With AMI: A Retrospective Study Based on the Angio-IMR

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel

• Registration Number: NCT05978726
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Coronary microvascular dysfunction (CMD) is increasingly recognized as an important indicator for long-term prognosis in patients with acute myocardial infarction (AMI). The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free measure for CMD in patients with AMI. Ticagrelor has recently been suggested to have additional benefits on coronary microcirculation beyond its antiplatelet effect. This study was designed to compare the protective effects of ticagrelor and clopidogrel on CMD and prognostic impact in patients with AMI, using the angio-IMR as a novel assessment tool.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2020-05-30
• Study Completion: 2022-05-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

• Patients who were diagnosed with AMI, including STEMI and NSTEMI, and underwent successful PCI and routine follow-up coronary angiography at the Second Affiliated Hospital of Zhejiang University School of Medicine between June 1, 2017 and May 31, 2020.

Exclusion Criteria

• 1. prior treatment with any P2Y12 inhibitor;
• 2. need for long-term oral anticoagulation therapy;
• 3. previous coronary artery bypass grafting (CABG);
• 4. chronic renal dysfunction with estimated glomerular filtration rate (eGFR) <30 mL/ (min·1.73 m2) or on hemodialysis;
• 5. liver cirrhosis ≥Child-Pugh B class;
• 6. cancer;
• 7. adjustment of dual antiplatelet therapy (DAPT) during follow-up;
• 8. inadequate coronary angiographic images.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ticagrelor maintenance treatment group	Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel	Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and ticagrelor 90mg twice daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography.

Primary Outcome Measures

Name	Time	Method
The improvement of angio-IMR	within 24 months post-PCI	Difference between Angio-IMR at follow-up coronary angiography and Angio-IMR after PCI

Secondary Outcome Measures

Name	Time	Method
Readmission for heart failure	Within 24 months post-PCI	Readmission for an acute exacerbation of chronic heart failure or acute heart failure
Myocardial reinfarction	Within 24 months post-PCI	Another myocardial infarction with elevated myocardial enzymes and abnormal electrocardiograms
Target vessel revascularization	Within 24 months post-PCI	Repeat revascularization was performed because of ischemia in the target-vessel territory
Non-target vessel revascularization	Within 24 months post-PCI	Repeat revascularization was performed because of ischemia in the non-target vessel territory
Cerebral hemorrhage	Within 24 months post-PCI	The occurrence of cerebral hemorrhage during the follow-up period was based on imaging CT and MRI
Other bleeding events	Within 24 months post-PCI	Bleeding events such as gingival bleeding, skin bleeding, and gastrointestinal bleeding and so on, occurred during the follow-up period

Trial Locations

Locations (1)

Second affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China