Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation

Coronary Artery Disease Clinical Trial

— STAMP-DES  

Official title:

Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation : STAMP-DES Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02494284
• Other study ID #: AMCCV2014-09
• Status: Terminated
• Phase: Phase 4
• First received: July 5, 2015
• Last updated: February 20, 2017
• Start date: December 22, 2015
• Est. completion date: February 13, 2017

Study information

• Verified date: February 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare short-term (6-month Dual Anti Platelet Therapy(DAPT) followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy) on clinically relevant bleeding complications (Bleeding Academic Research Consortium(BARC) type 2, 3, or 5)31 in patients after zotarolimus-eluting stent implantation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 364
• Est. completion date: February 13, 2017
• Est. primary completion date: February 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Men or women at least 19 years of age

• Patients with stable coronary artery disease who were successfully treated with zotarolimus-eluting stents

• Patients without major bleeding or MACE (myocardial infarction, stent thrombosis, stoke, repeat revascularization) within 6 months after zotarolimus-eluting stent placement

• 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:

• Persistent thrombocytopenia (platelet count <100,000/µl)

• A known intolerance to a study drug (aspirin, clopidogrel)

• Patients requiring long-term oral anticoagulants or cilostazol

• Patients presented with acute myocardial infarction (STEMI or NSTEMI) at the time of index procedure

• Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within 18 months after procedure

• Bare-metal stent implantation at the time of index procedure

• Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).

• A diagnosis of cancer in the past 2 years or current treatment for the active cancer.

• Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.

• Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).

• History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).

• Unwillingness or inability to comply with the procedures described in this protocol.

• Patients pregnant or breast-feeding or child-bearing potential.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel
6-month DAPT followed by clopidogrel monotherapy
• Aspirin plus clopidogrel
standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy)

Locations

Country	Name	City	State
Korea, Republic of	Cheju Halla General Hospital	Cheju
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Eulji University Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Medical Center	Seoul
Korea, Republic of	Kyunghee University Medical Center	Seoul
Korea, Republic of	SMA-SNU Boramae Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea St. Paul's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (4)

Lead Sponsor	Collaborator
CHEOL WHAN LEE, M.D., Ph.D	CardioVascular Research Foundation, Korea, Chong Kun Dang Pharmaceutical Corp., Medtronic

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with clinically relevant bleeding	clinically relevant bleeding (Bleeding Academic Research Consortium Definition: type 2, 3, or 5) at 18 months after randomization (6-24 months after the procedure)	18 months
Secondary	Number of participants with death from cardiovascular cause		18 months
Secondary	Number of participants with myocardial infarction		18 months
Secondary	Number of participants with stroke		18 months
Secondary	Number of participants with stent thrombosis		18 months
Secondary	Number of participants with repeat revascularization		18 months
Secondary	Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5		18 months
Secondary	Number of participants with a composite of death from vascular causes or myocardial infarction		18 months
Secondary	Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis		18 months
Secondary	Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5		18 months
Secondary	Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding)		18 months
Secondary	Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects.		18 months