TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI

Coronary Stenoses Clinical Trial

— TAILORED-CHIP  

Official title:

Comparison of Tailored Antiplatelet Therapy With Early Escalation and Late De-Escalation Strategy Versus Standard Dual Antiplatelet Therapy in Patients Undergoing Complex High-Risk Percutaneous Coronary Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03465644
• Other study ID #: AMCCV2018-03
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 12, 2019
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2018
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Age 19 and more

2. Subjects who scheduled for percutaneous coronary intervention(PCI) with contemporary drug-eluting stent

3. Patients must have at least one of any features of complex high-risk anatomic, procedural, or clinical-related factors;

• Clinical factors: diabetes, chronic kidney disease (i.e. creatinine clearance <60 mL/min), or low left ventricular ejection fraction (<40%) or

• Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, diffuse long lesion (lesion length = at least 30 mm), multi-vessel PCI (= 2 vessels requiring stent implantation), =3 requiring stent implantation, = 3 lesions will be treated, or predicted total stent length for revascularization > 60 mm

4. The patient or guardian agreed to the study protocol and the schedule of clinical follow-up and provided informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site.

Exclusion Criteria:

1. Enzyme-positive Acute myocardial infarction (non-ST-elevation myocardial infarction (NSTEMI) or ST Elevation Myocardial Infarction (STEMI))

2. Contraindication to aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel)

3. Use of Gp IIb/IIIa inhibitors at randomization

4. Cardiogenic shock

5. Treatment with only bare-metal stent (BMS) or balloon angioplasty during the index procedure.

6. Requirements for chronic oral anticoagulation (warfarin or Non-vitamin K antagonist oral anticoagulant (NOACs))

7. Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding)

8. History of intracranial hemorrhage or intracranial aneurysm

9. Planned surgery within 180 days

10. Severe liver disease (ascites and/or coagulopathy) or Dialysis-dependent renal failure at screening

11. Platelet count <80,000 cells/mm3 or hemoglobin level <10 g/dL

12. At risk of bradycardia (subjects with sinus node dysfunction or atrioventricular block more than 2nd degree but without a permanent pacemaker)

13. Use of strong cytochrome P-450 3A inhibitor or inducers within 2 week of the date of enrollment

: ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampin/rifampicin, rifabutin, dexamethasone, phenytoin, carbamazepine, phenobarbital

14. Pregnant and/or lactating women.

15. Concurrent medical condition with a life expectancy of less than 1 years

16. Active participation in another investigational study of a drug or device that has not completed the primary endpoint or follow-up period

17. Inability to provide written informed consent or participate in long-term follow-up

Related Conditions & MeSH terms

• Coronary Stenoses
• Coronary Stenosis

Intervention

Drug:
• Tailored antithrombotic strategy
Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months
• Conventional antithrombotic strategy
Clopidogrel + aspirin for 12months

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Chungbuk National University Hospital	Cheonju
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Dong-A Medical Center	Pusan
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Bundang CHA Hospital	Seongnam
Korea, Republic of	Seoul university Bundang hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	The Catholic Univ. of Korea Eunpyeong St. Mary's hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	St.Carollo Hospital	Suncheon
Korea, Republic of	The Catholic University of Korea, ST. Mary's Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Duk-Woo Park, MD	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net clinical outcome	a net clinical outcome of all-cause death, myocardial infarction, stroke, stent thrombosis, urgent revascularization or clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5] at 12 months after randomisation	1 year
Secondary	Death	Efficacy outcomes: any, cardiovascular, or non-cardiovascular cause death	1 year
Secondary	Myocardial infarction	Efficacy outcomes: any, periprocedural, or spontaneous Myocardial infarction	1 year
Secondary	Stroke	Efficacy outcomes: any, ischemic, or hemorrhagic Stroke	1 year
Secondary	Stent thrombosis	Efficacy outcomes	1 year
Secondary	Repeat revascularisation	Efficacy outcomes: any, target-vessel, or non-target-vessel Repeat revascularisation	1 year
Secondary	Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization)	Efficacy outcomes	1 year
Secondary	Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke)	Efficacy outcomes	1 year
Secondary	BARC major bleeding (type 3 or 5 bleeding)	Safety outcomes: Bleeding Academic Research Consortium	1 year
Secondary	TIMI major or minor bleeding	Safety outcomes: Thrombolysis In Myocardial Infarction	1 year
Secondary	GUSTO moderate or severe bleeding	Safety outcomes: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries	1 year
Secondary	ISTH major bleeding	Safety outcomes: International Society of Thrombosis and Hemostasis; PCI, percutaneous coronary intervention	1 year
Secondary	Any major or minor bleeding	Safety outcomes	1 year