ASET JAPAN

ASET-JAPAN The Acetyl Salicylic Elimination Trial

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Endpoints

Primary Ischemic Endpoint
Composite of cardiac death, target-vessel myocardial infarction (spontaneous: >48 hours following PCI) or definite stent thrombosis at 3 months for CCS patients (Phase 1) and at 12 months for NSTE-ACS patients (Phase 2).
Primary Bleeding Endpoint
Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 3 months for CCS patients (Phase 1) and at 12 months for NSTE-ACS patients (Phase 2).
Secondary endpoints (evaluated at each follow-up visit/contact)
All-cause death, stroke, all (spontaneous) MIs, repeat revascularization, definite/probable/possible stent thrombosis, BARC type 1-5 bleeding and each individual component of the primary endpoint.

References

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  2. Shen AY, Yao JF, Brar SS, Jorgensen MB, Chen W. Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation. J Am Coll Cardiol 2007;50(4):309-15.
  3. Levine GN, Jeong YH, Goto S, Anderson JL, Huo Y, Mega JL, Taubert K, Smith SC, Jr. Expert consensus document: World Heart Federation expert consensus statement on antiplatelet therapy in East Asian patients with ACS or undergoing PCI. Nat Rev Cardiol 2014;11(10):597-606.
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  5. Nakamura M, Kozuma K, Kitazono T, Iizuka T, Sekine T, Shiosakai K, Usui I, Kogure S. Prasugrel for Japanese Patients With Ischemic Heart Disease in Long-Term Clinical Practice (PRASFIT-Practice II)　- A 3-Month Interim Analysis of a Postmarketing Observational Study. Circ J 2019;83(3):637-646.
  6. Nakamura M, Morino Y, Kakuta T, Hata Y, Takamisawa I, Tanabe K, Anzai H, Takahashi A, Kadota K, Suzuki H, Wakatsuki T, Okayama H, Yamashita J, Akasaka T, Yokoi H, Nakagami T, Higuchi Y, Yamaguchi J, Kimura T, Harada A, Kuroda T, Takita A, Iijima R, Murakami Y, Saito S. Monotherapy With Prasugrel After Dual-Antiplatelet Therapy for Japanese Percutaneous Coronary Intervention Patients With High Bleeding Risk　- A Prospective Cohort Study (PENDULUM mono Study). Circ J 2020;85(1):27-36.