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

NCT05567536 | Active Not Recruiting DMC FDA Drug

• 1 other identifier: 1208-028-421
• Study Type: observational
• Target: 5,530
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Disease; Atheroscleroses, Coronary

Keywords

percutenous coronary intervention; drug-eluting stent; chronic maintenance period

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Thrombotic outcome

  From date of randomization until March, 2022.

• Bleeding outcome

  From date of randomization until March, 2022.

Other Outcomes (2)

• All-cause death

  From date of randomization until March, 2022.

• Cardiac death

  From date of randomization until March, 2022.

Study Arms (2)

Clopidogrel group

This group are those who received clopidogrel 75mg qd as a single antiplatelet agent therapy after PCI.

Drug: Antiplatelet Agents

Aspirin group

This group are those who received aspirin 100mg qd as a single antiplatelet agent therapy after PCI.

Drug: Antiplatelet Agents

Interventions

Antiplatelet Agents DRUG

Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent

Aspirin group; Clopidogrel group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were enrolled in the HOST-EXAM randomized clinical trial will be analyzed for an extended follow-up duration. Patients enrolled in the HOST-EXAM trial were patients that received stenting with a drug-eluting stent and had successfully completed 6-18 months of DAPT without events.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Related Publications (2)

• 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 after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial. Lancet. 2021 Jun 26;397(10293):2487-2496. doi: 10.1016/S0140-6736(21)01063-1. Epub 2021 May 16.

  PMID: 34010616 RESULT

• 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 disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009 May 30;373(9678):1849-60. doi: 10.1016/S0140-6736(09)60503-1.

  PMID: 19482214 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Platelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Internal Medicine

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 5, 2022
• Study Start: March 1, 2014
• Primary Completion: October 1, 2022
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share