Association of Clopidogrel Therapy and Stent Thrombosis (REAL-LATE)

This study has been completed.
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00484926
First received: June 11, 2007
Last updated: August 9, 2012
Last verified: August 2012

June 11, 2007
August 9, 2012
March 2007
March 2010   (final data collection date for primary outcome measure)
The composite of cardiac death or MI in the intent-to-treat population [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]
The composite of cardiac death or MI in the intent-to-treat population [ Time Frame: 1 year after randomization ]
Complete list of historical versions of study NCT00484926 on ClinicalTrials.gov Archive Site
  • All death [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]
  • Bleeding events [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]
  • All death [ Time Frame: 1 year after randomization ]
  • Myocardial infarction [ Time Frame: 1 year after randomization ]
  • Stroke [ Time Frame: 1 year after randomization ]
  • Stent Thrombosis [ Time Frame: 1 year after randomization ]
  • Bleeding events [ Time Frame: 1 year after randomization ]
Not Provided
Not Provided
 
Association of Clopidogrel Therapy and Stent Thrombosis
Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated With Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events

The purpose of REAL-LATE (Correlation of Clopidogrel Therapy Discontinuation in REAL-world Patients Treated with Drug-Eluting Stent Implantation and Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between clopidogrel use and long-term rates of cardiac death or MI after DES implantation in real-world practice and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.

An observational analysis from BASKET-LATE (Basel Stent Kosten-Effekivitats Trial-Late Thrombotic Events) examined the incidence of clinical events after cessation of clopidogrel therapy. This study identified 746 patients who were without major adverse events 6 months after drug-eluting or bare-metal stent placement. All patients had stopped taking clopidogrel and were followed up for an additional 12 months. At 18-month follow-up, there was no difference between patients with a drug-eluting or bare-metal stent in cumulative rates of death or myocardial infarction (MI). However, after clopidogrel discontinuation patients receiving drug-eluting vs bare-metal stents experienced higher rates of death and MI (4.9% vs 1.3%, respectively). These results have created uncertainty regarding the minimal necessary duration of antiplatelet therapy after drug-eluting stent implantation. Also, there remains widespread uncertainty regarding the risk of clinical events after the discontinuation of clopidogrel, particularly after DES implantation.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Aspirin monotherapy
    stopping clopidogrel at 1 year after DES
    Other Name: Aspirin monotherapy
  • Drug: Aspirin,Clopidogrel
    continue aspirin and clopidogrel 1year after DES
    Other Name: Aspirin,Clopidogrel Dual antiplatelet therapy
  • Active Comparator: Aspirin
    Aspirin monotherapy (stopping clopidogrel at 1 year after DES)
    Intervention: Drug: Aspirin monotherapy
  • Experimental: Aspirin,Clopidogrel
    Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)
    Intervention: Drug: Aspirin,Clopidogrel
Park SJ, Park DW, Kim YH, Kang SJ, Lee SW, Lee CW, Han KH, Park SW, Yun SC, Lee SG, Rha SW, Seong IW, Jeong MH, Hur SH, Lee NH, Yoon J, Yang JY, Lee BK, Choi YJ, Chung WS, Lim DS, Cheong SS, Kim KS, Chae JK, Nah DY, Jeon DS, Seung KB, Jang JS, Park HS, Lee K. Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med. 2010 Apr 15;362(15):1374-82. doi: 10.1056/NEJMoa1001266. Epub 2010 Mar 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Among consecutive patients treated with DES, event-free patients who survived at least the first 12 months without nonfatal MI or repeat revascularization
  2. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  1. Contraindication to antiplatelet therapy (aspirin or clopidogrel)
  2. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  3. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  4. Concurrent bleeding diathesis or major bleeding history requiring discontinuation of antiplatelet drugs.
  5. Patients with left main stem stenosis (>50% by visual estimate) or left main stenting
  6. Concomitant disease requiring long-term use of clopidogrel (stroke, peripheral vascular disease, significant carotid a. disease, etc)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00484926
20070186
Yes
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
CardioVascular Research Foundation, Korea
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
CardioVascular Research Foundation, Korea
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP