Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation
Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Angiography; Antiplatelet Agents
Intervention: Clopidogrel (Drug); Aspirin plus clopidogrel (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: CHEOL WHAN LEE, M.D., Ph.D Official(s) and/or principal investigator(s): Seung-Jung Park, MD, Principal Investigator, Affiliation: Asan Medical Center Cheol-Whan Lee, MD, Principal Investigator, Affiliation: Asan Medical Center
Overall contact: Cheol-Whan Lee, MD, Email: cheolwlee@amc.seoul.kr
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.
Clinical Details
Official title: Short-Term Dual Antiplatelet and Maintenance CloPidogrel Therapy After Drug-Eluting Stent Implantation : STAMP-DES Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of participants with clinically relevant bleeding
Secondary outcome: Number of participants with death from cardiovascular causeNumber of participants with myocardial infarction Number of participants with stroke Number of participants with stent thrombosis Number of participants with repeat revascularization Number of participants with BARC(Bleeding Academic Research Consortium Definition) type 3 or 5 Number of participants with a composite of death from vascular causes or myocardial infarction Number of participants with a composite of death from cardiovascular causes, myocardial infarction, stroke, stent thrombosis Number of participants with a composite of death from vascular causes, myocardial infarction, stroke, stent thrombosis, BARC type 3 or 5 Number of participants with gastrointestinal side effects (gastric or duodenal active ulcer, perforation, gastrointestinal bleeding) Number of participants with a composite of BARC(Bleeding Academic Research Consortium Definition) 2, 3, 5 or gastrointestinal side effects.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men or women at least 18 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.
Locations and Contacts
Cheol-Whan Lee, MD, Email: cheolwlee@amc.seoul.kr
Soonchunhyang Univ. Bucheon Hospital, Bucheon, Korea, Republic of; Not yet recruiting Nae-Hee Lee, MD, Email: naeheelee@naver.com Nae-Hee Lee, MD, Principal Investigator
Cheju Halla General Hospital, Cheju, Korea, Republic of; Not yet recruiting Sung-Won Cho, MD, Email: awake61@yahoo.co.kr Sung-Won Cho, MD, Principal Investigator
Daegu Catholic University Medical Center, Daegu, Korea, Republic of; Not yet recruiting Kee-Sik Kim, MD, Email: kks7379@cu.ac.kr Kee-Sik Kim, MD, Principal Investigator
Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of; Not yet recruiting Chang-Wook Nam, MD, Email: ncwcv@dsmc.or.kr Chang-Wook Nam, MD, Principal Investigator
Eulji University Hospital, Daejeon, Korea, Republic of; Not yet recruiting Yu-Jeong Choi, MD, Email: imedicana@eulji.ac.kr Yu-Jeong Choi, MD, Principal Investigator
The Catholic University of Korea, Daejeon ST. Mary's Hospital, Daejeon, Korea, Republic of; Not yet recruiting Man-Won Park, MD, Email: pmw6193@catholic.ac.kr Man-Won Park, MD, Principal Investigator
Gangneung Asan Hospital, Gangneung, Korea, Republic of; Not yet recruiting Sang-Sig Cheong, MD, Email: sscheong@gnah.co.kr Sang-Sig Cheong, MD, Principal Investigator
Inje University Ilsan Paik Hospital, Ilsan, Korea, Republic of; Not yet recruiting Sung-Yun Lee, MD, Email: im2pci@gmail.com Sung-Yun Lee, MD, Principal Investigator
Gachon University Gil Hospital, Incheon, Korea, Republic of; Not yet recruiting Tae-Hoon Ahn, MD, Email: encore@gilhospital.com Tae-Hoon Ahn, MD, Principal Investigator
Pusan National University Hospital, Pusan, Korea, Republic of; Not yet recruiting Kwang-Soo Cha, MD, Email: cks@pusan.ac.kr Kwang-Soo Cha, MD, Principal Investigator
Asan Medical Center, Seoul, Korea, Republic of; Recruiting Sun-Hwa Lee, Project Leader, Email: cvcrc13@amc.seoul.kr Cheol-Whan Lee, MD, Principal Investigator
Kangbuk Samsung Medical Center, Seoul, Korea, Republic of; Not yet recruiting Bum-Soo Kim, MD, Email: bsmed.kim@samsung.com Bum-Soo Kim, MD, Principal Investigator
Kyunghee University Medical Center, Seoul, Korea, Republic of; Not yet recruiting Won Kim, MD, Email: mylovekw@hanmail.net Won Kim, MD, Principal Investigator
SMA-SNU Boramae Medical Center, Seoul, Korea, Republic of; Not yet recruiting Woo-Young Chung, MD, Email: chungwy3023@daum.net Woo-Young Chung, MD, Principal Investigator
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea, Republic of; Not yet recruiting Ki-Yook Jang, MD, Email: kiyuk@catholic.ac.kr Ki-Yook Jang, MD, Principal Investigator
The Catholic University of Korea St. Paul's Hospital, Seoul, Korea, Republic of; Not yet recruiting Byung-Hee Hwang, MD, Email: hbhmac@naver.com Byung-Hee Hwang, MD, Principal Investigator
The Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul, Korea, Republic of; Not yet recruiting Cheol-Su Park, MD, Email: charlie@catholic.ac.kr Cheol-Su Park, MD, Principal Investigator
The Catholic University of Korea St. Vincent's Hospital, Suwon, Korea, Republic of; Not yet recruiting Ki-Dong Yoo, MD, Email: cardioyoo@gmail.com Ki-Dong Yoo, MD, Principal Investigator
The Catholic University of Korea Uijeongbu St. Mary's Hospital, Uijeongbu, Korea, Republic of; Not yet recruiting Jong-Min Lee, MD, Email: leejongm@catholic.ac.kr Jong-Min Lee, MD, Principal Investigator
Ulsan University Hospital, Ulsan, Korea, Republic of; Not yet recruiting Sang-Gon Lee, MD, Email: sglee@uuh.ulsan.kr Sang-Gon Lee, MD, Principal Investigator
Additional Information
Starting date: June 2015
Last updated: July 8, 2015
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