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

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Clopidogrel; Drug: Aspirin plus clopidogrel

• Study Type: Interventional
• Enrollment (Actual): 364
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheju, Korea, Republic of
    • Cheju Halla General Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • Eulji University Hospital
  • Gangneung, Korea, Republic of
    • Gangneung Asan Hospital
  • Ilsan, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Kyunghee University Medical Center
  • Seoul, Korea, Republic of
    • Kangbuk Samsung 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
    • SMA-SNU Boramae Medical Center
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short term dual therapy	Drug: Clopidogrel; 6-month DAPT followed by clopidogrel monotherapy
Active Comparator: Long term dual therapy	Drug: Aspirin plus clopidogrel; standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of participants with death from cardiovascular cause	18 months
Number of participants with myocardial infarction	18 months
Number of participants with stroke	18 months
Number of participants with stent thrombosis	18 months
Number of participants with repeat revascularization	18 months
Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5	18 months
Number of participants with a composite of death from vascular causes or myocardial infarction	18 months
Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis	18 months
Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5	18 months
Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding)	18 months
Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects.	18 months

Collaborators and Investigators

• Sponsor: CHEOL WHAN LEE, M.D., Ph.D
• Collaborators: Medtronic; CardioVascular Research Foundation, Korea; Chong Kun Dang Pharmaceutical Corp.
• Investigators: Principal Investigator: Seung-jung Park, MD, Asan Medical Center; Principal Investigator: Cheol-Whan Lee, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2015
• Primary Completion (Actual): February 13, 2017
• Study Completion (Actual): February 13, 2017

Study Registration Dates

• First Submitted: July 5, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Coronary artery disease; Drug eluting stent; Dual antiplatelet platelet therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: AMCCV2014-09