OPT-CAD Score GUIded Dual ANtiplatelet De-esCalation Time

NCT06216821 | Recruiting DMC

• 1 other identifier: OPT-GUIDANCE V1.0
• Study Type: interventional
• Target: 3,490
• Locations: 1 country
• Sites: 1

Brief Summary

Monotherapy with a P2Y12 inhibitor after a minimum period of DAPT following percutaneous coronary intervention (PCI) is an emerging de-escalation antiplatelet strategy in recent years. However, the optimal timing for de-escalating DAPT in ACS patients undergoing PCI remains debated. The OPT-CAD score is a risk stratification tool derived from Chinese patients which has been demonstrated superior predictive capabilities for ischemic events and all-cause mortality than the GRACE score. Therefore, we hypothesize that the OPT-CAD score can be used to guide the timing of the DAPT de-escalation strategy to monotherapy with P2Y12 inhibitors for ACS patients, that is, low-risk patients could be de-escalated after 1 month, while high-risk patients could be de-escalated after 3 months, so as to achieve individualized antithrombotic therapy and maximize patient benefit.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Net adverse clinical events (NACE)

  NACE is defined as a composite of all cause death, myocardial infarction, stroke, stent thrombosis or BARC type 2,3, 5 bleeding

  12 months

Secondary Outcomes (5)

• BARC type 2,3, or 5 bleeding

  3 months and 12 months

• BARC type 3 or 5 bleeding

  3 months and 12 months

• Major adverse cardiac and cerebral events (MACE)

  3 months and 12 months

• All cause death

  3 months and 12 months

• Stent thrombosis

  3 months and 12 months

Study Arms (2)

Standard DAPT therapy

ACTIVE COMPARATOR

Standard DAPT therapy for 12 mouths

Drug: standard DAPT

OPT-CAD score guided de-escalation DAPT therapy

EXPERIMENTAL

Patients at moderate to high risk of ischemic events assessed by the OPT-CAD score will receive DAPT therapy for 3 months followed by P2Y12 inhibitor monotherapy for 9 months; Patients at low risk of ischemic events assessed by the OPT-CAD score will receive DAPT for 1 month follow by P2Y12 inhibitor monotherapy for 11 months.

Drug: OPT-CAD score guided DAPT de-escalation

Interventions

standard DAPT DRUG

standard DAPT with aspirin and a P2Y12 inhibitor for 12 months after DES implantation.

Standard DAPT therapy

OPT-CAD score guided DAPT de-escalation DRUG

De-escalation DAPT at 3 months for moderate to high risk patients and de-escalation DAPT at 1 month for low risk patients.

OPT-CAD score guided de-escalation DAPT therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with ages of 18-80 years;
• Patients with clinically diagnosed ACS who have undergone at least one DES implantation;
• Individuals capable of completing the OPT-CAD scoring calculation;
• Researchers assessing that participants can tolerate at least a 12-month duration of DAPT therapy;
• Written informed consent provided.

You may not qualify if:

• Left main coronary artery lesion PCI;
• Allergy to study drugs such as aspirin, clopidogrel, or ticagrelor;
• Meeting 1 major or 2 minor criteria for high bleeding risk according to the ARC-HBR criteria;
• Anticipated need for revascularization or surgical intervention within 12 months;
• Severe ischemia or hemorrhage events during the current hospitalization;
• Life expectancy of other serious diseases is less than 1 year;
• Pregnant or women of childbearing age who intend to conceive within 1 year;
• Participation in other clinical trials while still under observation;
• Researchers considering ineligibility for enrollment.

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

RECRUITING

Related Publications (15)

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  PMID: 32860058 BACKGROUND

• Kim BK, Hong SJ, Cho YH, Yun KH, Kim YH, Suh Y, Cho JY, Her AY, Cho S, Jeon DW, Yoo SY, Cho DK, Hong BK, Kwon H, Ahn CM, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; TICO Investigators. Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2407-2416. doi: 10.1001/jama.2020.7580.

  PMID: 32543684 BACKGROUND

• Mehran R, Baber U, Sharma SK, Cohen DJ, Angiolillo DJ, Briguori C, Cha JY, Collier T, Dangas G, Dudek D, Dzavik V, Escaned J, Gil R, Gurbel P, Hamm CW, Henry T, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Marx SO, Mehta SR, Moliterno D, Ohman EM, Oldroyd K, Sardella G, Sartori S, Shlofmitz R, Steg PG, Weisz G, Witzenbichler B, Han YL, Pocock S, Gibson CM. Ticagrelor with or without Aspirin in High-Risk Patients after PCI. N Engl J Med. 2019 Nov 21;381(21):2032-2042. doi: 10.1056/NEJMoa1908419. Epub 2019 Sep 26.

  PMID: 31556978 BACKGROUND

• Hahn JY, Song YB, Oh JH, Chun WJ, Park YH, Jang WJ, Im ES, Jeong JO, Cho BR, Oh SK, Yun KH, Cho DK, Lee JY, Koh YY, Bae JW, Choi JW, Lee WS, Yoon HJ, Lee SU, Cho JH, Choi WG, Rha SW, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC; SMART-CHOICE Investigators. Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2428-2437. doi: 10.1001/jama.2019.8146.

  PMID: 31237645 BACKGROUND

• Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, Hata Y, Yagi M, Suematsu N, Yokomatsu T, Takamisawa I, Doi M, Noda T, Okayama H, Seino Y, Tada T, Sakamoto H, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Hanaoka KI, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 Investigators. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2414-2427. doi: 10.1001/jama.2019.8145.

  PMID: 31237644 BACKGROUND

• Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Ogita M, Suwa S, Isawa T, Domei T, Yamaji K, Tatsushima S, Watanabe H, Ohya M, Tokuyama H, Tada T, Sakamoto H, Mori H, Suzuki H, Nishikura T, Wakabayashi K, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 ACS Investigators. Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome: The STOPDAPT-2 ACS Randomized Clinical Trial. JAMA Cardiol. 2022 Apr 1;7(4):407-417. doi: 10.1001/jamacardio.2021.5244.

  PMID: 35234821 BACKGROUND

• Han Y, Chen J, Qiu M, Li Y, Li J, Feng Y, Qiu J, Meng L, Sun Y, Tao G, Wu Z, Yang C, Guo J, Pu K, Chen S, Wang X. Predicting long-term ischemic events using routine clinical parameters in patients with coronary artery disease: The OPT-CAD risk score. Cardiovasc Ther. 2018 Oct;36(5):e12441. doi: 10.1111/1755-5922.12441. Epub 2018 Jun 28.

  PMID: 29869835 BACKGROUND

• Li X, Qiu M, Na K, Li Y, Ma S, Qi Z, Li J, Li Y, Han Y. Comparison of the efficacy and safety of ticagrelor and clopidogrel in patients with acute coronary syndrome after risk stratification. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:1032-1039. doi: 10.1002/ccd.29591. Epub 2021 Mar 2.

  PMID: 33650763 BACKGROUND

• Zhao Y, Li J, Ma S, Jiang Z, Li Z, Wang X, Han Y, Li Y. Impact of extended dual antiplatelet therapy on long-term prognosis in patients with acute coronary syndrome complicated with anemia: A sub-analysis of the real-world OPT-CAD study. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E235-E242. doi: 10.1002/ccd.29676. Epub 2021 Apr 5.

  PMID: 33817946 BACKGROUND

• Ma S, Jiang Z, Qiu M, Li Z, Bian L, Li Y, Han Y. Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study. Adv Ther. 2020 Jul;37(7):3150-3161. doi: 10.1007/s12325-020-01376-0. Epub 2020 May 16.

  PMID: 32418142 BACKGROUND

• Wang H, Qi J, Li Y, Tang Y, Li C, Li J, Han Y. Pharmacodynamics and pharmacokinetics of ticagrelor vs. clopidogrel in patients with acute coronary syndromes and chronic kidney disease. Br J Clin Pharmacol. 2018 Jan;84(1):88-96. doi: 10.1111/bcp.13436. Epub 2017 Nov 3.

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• Han Y, Liao Z, Li Y, Zhao X, Ma S, Bao D, Qiu M, Deng J, Wang J, Qu P, Jiang C, Jia S, Yang S, Ru L, Feng J, Gao W, Huang Y, Tao L, Han Y, Yang K, Wang X, Zhang W, Wang B, Li Y, Yang Y, Li J, Sheng J, Ma Y, Cui M, Ma S, Wang X, Li Z, Stone GW. Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury. J Am Coll Cardiol. 2022 Jan 18;79(2):116-128. doi: 10.1016/j.jacc.2021.10.028. Epub 2021 Nov 6.

  PMID: 34752902 BACKGROUND

• Li Y, Wang X, Bao D, Liao Z, Li J, Han X, Wang H, Xu K, Li Z, Stone GW, Han Y. Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial. Am Heart J. 2020 Oct;228:8-16. doi: 10.1016/j.ahj.2020.06.004. Epub 2020 Jun 15.

  PMID: 32745734 BACKGROUND

• Li Y, Jing Q, Wang B, Wang X, Li J, Qiao S, Chen S, Angiolillo DJ, Han Y. Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial. Am Heart J. 2020 Oct;228:1-7. doi: 10.1016/j.ahj.2020.07.005. Epub 2020 Jul 9.

  PMID: 32739652 BACKGROUND

• Han Y, Claessen BE, Chen SL, Chunguang Q, Zhou Y, Xu Y, Hailong L, Chen J, Qiang W, Zhang R, Luo S, Li Y, Zhu J, Zhao X, Cheng X, Wang J, Su X, Tao J, Sun Y, Wang G, Li Y, Bian L, Goel R, Sartori S, Zhang Z, Angiolillo DJ, Cohen DJ, Gibson CM, Kastrati A, Krucoff M, Mehta SR, Ohman EM, Steg PG, Liu Y, Dangas G, Sharma S, Baber U, Mehran R. Ticagrelor With or Without Aspirin in Chinese Patients Undergoing Percutaneous Coronary Intervention: A TWILIGHT China Substudy. Circ Cardiovasc Interv. 2022 Apr;15(4):e009495. doi: 10.1161/CIRCINTERVENTIONS.120.009495. Epub 2022 Mar 23.

  PMID: 35317615 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yaling Han, PhD

  The General Hospital of Northern Theater Command

  STUDY CHAIR

Central Study Contacts

Yi Li, PhD

CONTACT

+86-24-28897309; doctorliyi@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)