Aspirin and a Potent P2Y12 Inhibitor Versus Aspirin and Clopidogrel Therapy in Patients Undergoing Elective Percutaneous Coronary Intervention for Complex Lesion Treatment (SMART-ATTEMPT)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study is a prospective, open label, two-arm, randomized multicenter trial to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective percutaneous coronary intervention with drug eluting stents for complex coronary lesions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 75
Healthy Volunteers: f
View:

• ① Subject must be at least 19 years of age

• ② Subject who can verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure

• ③ Patients undergoing elective PCI as follows:

‣ True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5 mm size

⁃ Chronic total occlusion (≥3 months) as target lesion

⁃ PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions)

⁃ Long coronary lesions (expected stent length ≥38 mm)

⁃ Multi-vessel PCI (≥2 vessels treated at one PCI session)

⁃ Multiple stent needed (≥3 stents per patient)

⁃ In-stent restenosis lesion as target lesion

⁃ Severely calcified lesion (encircling calcium in angiography)

⁃ Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Joo-Yong Hahn, MD, PhD
ichjy1@gmail.com
82-2-3410-1246
Backup
Ki hong Choi, MD, PhD
cardiokh@gmail.com
82-2-3410-3419
Time Frame
Start Date: 2020-01-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 3500
Treatments
Active_comparator: Prasugrel plus Aspirin arm
Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of prasugrel 60 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus prasugrel 10 mg once daily\* will be given for one year.~\* Based on previous studies including PRASFIT-ACS (PRASugrel compared with clopidogrel For Japanese patIenTs with ACS undergoing PCI) or TRILOGY ACS (The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes), maintenance dose can be reduced to 5 mg once daily in patients with high bleeding risk or by investigator's medical judgement.
Active_comparator: Clopidogrel plus Aspirin arm
Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of clopidogrel 600 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for one year.
Sponsors
Collaborators: Mediplex Sejong Hospital, Yeungnam University Hospital, Wonkwang University Hospital, Chonnam National University Hospital, Dankook University, Gyeongsang National University Hospital, Chungbuk National University Hospital, Seoul St. Mary's Hospital, Ewha Womans University Seoul Hospital, Chungnam National University Hospital, Keimyung University Dongsan Medical Center, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Incheon St.Mary's Hospital, Gachon University Gil Medical Center, Sejong General Hospital, Soonchunhyang University Hospital, Wonju Severance Christian Hospital, Konkuk University Chungju Hospital, Inje University Ilsan Paik Hospital
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov

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