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Completed

NCT Number: NCT05978726

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

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Second affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dual antiplatelet therapy with aspirin and either ticagrelor or clopidogrel

Drug

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.

Primary outcomes

  1. The improvement of angio-IMR

    Time frame: within 24 months post-PCI

    Difference between Angio-IMR at follow-up coronary angiography and Angio-IMR after PCI

Secondary outcomes

  1. Readmission for heart failure

    Time frame: Within 24 months post-PCI

    Readmission for an acute exacerbation of chronic heart failure or acute heart failure

  2. Myocardial reinfarction

    Time frame: Within 24 months post-PCI

    Another myocardial infarction with elevated myocardial enzymes and abnormal electrocardiograms

  3. Target vessel revascularization

    Time frame: Within 24 months post-PCI

    Repeat revascularization was performed because of ischemia in the target-vessel territory

  4. Non-target vessel revascularization

    Time frame: Within 24 months post-PCI

    Repeat revascularization was performed because of ischemia in the non-target vessel territory

  5. Cerebral hemorrhage

    Time frame: Within 24 months post-PCI

    The occurrence of cerebral hemorrhage during the follow-up period was based on imaging CT and MRI

  6. Other bleeding events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Aug 7, 2023
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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