Long Term Follow-up of Comparison of Clopidogrel vs. Aspirin Monotherapy After Drug-eluting Stent Implantation

Coronary Artery Disease Clinical Trial

— HOST-EXAM-EX  

Official title:

HOST-EXAM-Ex : Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - EXtended Antiplatelet Monotherapy - EXtended Follow up

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05567536
• Other study ID #: 1208-028-421
• Status: Active, not recruiting
• Start date: March 1, 2014
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an retrospective extended study of a randomized clinical trial (The HOST-EXAM trial ClinicalTrials.gov Identifier: NCT02044250).

Investigators will perform a retrospective analysis of all participants enrolled in this trial will be performed, until the longest follow-up duration.

Description:

The HOST-EXAM trial (ClinicalTrials.gov Identifier: NCT02044250) was an randomized clinical trial that was performed to compare head-to-head, the efficacy and safety between aspirin and clopidogrel monotherapy in patients who received PCI for coronary artery disease and required chronic maintenance antiplatelet therapy. From March 2014 through May 2018, a total of 5438 patients were enrolled, and follow-up was performed upto 24 months after randomization. After this study, randomization was unlocked and patients were followed-up based on the standard protocol.

Afterwards, the current study was planned to perform a extended follow-up of the HOST-EXAM population. The specific drug by the randomization group in the HOST-EXAM trial was not mandatory after the initial 24 months, therefore participants received medication according to the current guidelines, and according to the physicians preferences.

This is a observational, retrospective analysis of all clinical events after the randomization period. The prescribed medications and any clinical events will be evaluated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5530
• Est. completion date: December 31, 2028
• Est. primary completion date: October 1, 2022
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients who were enrolled in the HOST-EXAM randomized clinical trial

Exclusion Criteria:

• None, otherwise the patient refuses to participate in this study, or refuses to provide personal medical information

Related Conditions & MeSH terms

• Atheroscleroses, Coronary
• Atherosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Drug:
• Antiplatelet Agents
Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

References & Publications (2)

Antithrombotic Trialists' (ATT) Collaboration, Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A. Aspirin in the primary and secondary prevention of vascular — View Citation

Koo BK, Kang J, Park KW, Rhee TM, Yang HM, Won KB, Rha SW, Bae JW, Lee NH, Hur SH, Yoon J, Park TH, Kim BS, Lim SW, Cho YH, Jeon DW, Kim SH, Han JK, Shin ES, Kim HS; HOST-EXAM investigators. Aspirin versus clopidogrel for chronic maintenance monotherapy a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause death	Death from any cause	From date of randomization until March, 2022.
Other	Cardiac death	Death from a cardiac cause	From date of randomization until March, 2022.
Primary	Patient oriented composite outcome	A composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding complication	From date of randomization until March, 2022.
Secondary	Thrombotic outcome	cardiac death, non-fatal MI, ischemic stroke, readmission due to ACS, and definite or probable stent thrombosis	From date of randomization until March, 2022.
Secondary	Bleeding outcome	Bleeding Academic Research Consortium (BARC) type =2 bleeding	From date of randomization until March, 2022.