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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Completed

CT.gov ID

NCT05978726

Collaborator

(none)

325

Enrollment

Location

58.9

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Drug: Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel

Study Design

Study Type:

Observational

Actual Enrollment :

325 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Ticagrelor Versus Clopidogrel for Coronary Microvascular Dysfunction in Patients With Acute Myocardial Infarction: A Retrospective Study Based on the Angiography-derived Index of Microcirculatory Resistance

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

May 30, 2020

Actual Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
ticagrelor maintenance treatment group 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.	Drug: Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel Patients with acute myocardial infarction randomly received dual antiplatelet therapy with with aspirin 100mg daily and either ticagrelor 90mg twice daily or clopidogrel 75mg once daily for at least 9 months after PCI as needed.
clopidogrel maintenance treatment group Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and clopidogrel 75mg once daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography.

Arm

Intervention/Treatment

ticagrelor maintenance treatment group

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.

Drug: Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel

Patients with acute myocardial infarction randomly received dual antiplatelet therapy with with aspirin 100mg daily and either ticagrelor 90mg twice daily or clopidogrel 75mg once daily for at least 9 months after PCI as needed.

clopidogrel maintenance treatment group

Patients received dual antiplatelet therapy (DAPT) with aspirin 100mg daily and clopidogrel 75mg once daily for at least 9 months after PCI. Angio-IMR assessment was performed after primary PCI and during routine follow-up coronary angiography.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

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,

Exclusion Criteria:

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