Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of

Status Recruiting

Clinical Trial Summary

Previous randomized clinical trials have deomonstrated the efficacy and safety of short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), however, the single antiplatelet agent to be maintained after short-term DAPT was different. Therefore, which antiplatelet agent to be maintained after short-term DAPT needs further invstigations.

Clinical Trial Description

The investigators hypothesized that short-term (1-3 months) DAPT followed by clopidogrel monotherapy will be superior to short-term DAPT followed by aspirin monotherapy after PCI in patients with ischemic heart disease. We will evaluate whether clopidogrel monotherapy will reduce the rate of net adverse clinical events (NACE) at 12 months compared to aspirin monotherapy after very-short term DAPT. Eligible patients will be randomized to short-term DAPT followed by clopidogrel monotherapy or short-term DAPT followed by aspirin monotherapy at hospitalization for index PCI. Randomization will be stratified according to 1) bleeding risk (high bleeding risk [HBR] or non-HBR), 2) clinical presentation (acute coronary syndrome or chronic coronary artery disease), and 3) lesion complexity (non-complex or complex lesion). Regarding the duration of very-short term DAPT, the maintenance duration of DAPT (1-month or 3-month) will be determined as follows: - If the patients are at HBR (HBR is defined according to ARC-HBR criteria: meeting at least 1 major or 2 minor criteria), 1-month DAPT will be given regardless of clinical presentation or lesion complexity. - In the patients are at non-HBR, 3-month DAPT will be given in those treated for unstable angina and/or complex lesions (complex lesion is defined as meeting at least one of the following: number of stents implanted ≥3, number of lesions treated ≥3, 3-vessel treated, bifurcation PCI with 2 stents, total stent length ≥60mm, or chronic total occlusion). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05320926
Study type	Interventional
Source	Yonsei University
Contact	Byeong-Keuk Kim
Phone	82-2228-8460
Email	kimbk@yuhs.ac
Status	Recruiting
Phase	N/A
Start date	July 26, 2022
Completion date	July 10, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT06002932` - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.	N/A
Active, not recruiting	`NCT04562805` - Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)	N/A
Recruiting	`NCT05292079` - CAPTURER PMCF Study ( rEPIC04D )
Recruiting	`NCT05292118` - Navitian PMCF Study ( rEPIC04C )
Recruiting	`NCT05292014` - ANGIOLITE PMCF Study ( rEPIC04F )
Recruiting	`NCT05292092` - Essential Pro PMCF Study ( rEPIC04E )
Completed	`NCT05292105` - NC Xperience PMCF Study( rEPIC04B)
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Not yet recruiting	`NCT04153383` - Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
Recruiting	`NCT02729064` - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose	Phase 1
Recruiting	`NCT02982434` - The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation	Phase 2
Completed	`NCT02468401` - Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions	N/A
Completed	`NCT02759406` - Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study	N/A
Recruiting	`NCT01681381` - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization	N/A
Completed	`NCT01699802` - Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)	N/A
Completed	`NCT01604213` - Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease	Phase 4
Completed	`NCT01724567` - Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training	N/A
Completed	`NCT01334268` - RESOLUTE China RCT	N/A
Completed	`NCT02159235` - Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms