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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 cause

Number 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/┬Ál)

- 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

Page last updated: August 23, 2015

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