OCT or Angiography Guided De-escalation of DAPT

NCT ID: NCT06339021

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-12-01

Brief Summary

Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality to accurately assess vessel and lumen geometry and identify the hallmark of a culprit lesion including plaque disruption and thrombus. In addition, the incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized OCT-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Regarding the antithrombotic therapy after revascularization, the 2023 ESC guidelines recommend the P2Y12 receptor inhibitor de-escalation (i.e. switching from ticagrelor to clopidogrel) in ACS patients may be considered as an alternative strategy to the default treatment regimen in order to reduce the risk of bleeding events.

Based on the above conclusions, we designed a single-center, prospective, randomized controlled, exploratory study trial to evaluate whether the utility of OCT for guiding PCI with DES followed by antiplatelet de-escalation therapy could further reduce the stent-induced intimal hyperplasia of STEMI patients after stent implantation.

Conditions

Optical Coherence Tomography; Dual Antiplatelet Therapy; Antiplatelet De-escalation; Neointimal Coverage; ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

OCT-guided PCI and DAPT De-escalation

OCT-guided PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients

Group Type: EXPERIMENTAL

OCT-guided PCI

Intervention Type: PROCEDURE

OCT-guided PCI based on MLD MAX algorithm

DAPT de-escalation

Intervention Type: DRUG

Aspirin and clopidogrel 30 days after DES implantation

OCT-guided PCI and default DAPT regimen

OCT-guided PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients

Group Type: EXPERIMENTAL

OCT-guided PCI

Intervention Type: PROCEDURE

OCT-guided PCI based on MLD MAX algorithm

default DAPT regimen

Intervention Type: DRUG

Aspirin and ticagrelor 30 days after DES implantation

Conventional angiography-based PCI and DAPT De-escalation

Conventional angiography-based PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients

Group Type: EXPERIMENTAL

Conventional angiography-based PCI

Intervention Type: PROCEDURE

Conventional angiography-based PCI

DAPT de-escalation

Intervention Type: DRUG

Aspirin and clopidogrel 30 days after DES implantation

Conventional angiography-based PCI and default DAPT regimen

Conventional angiography-based PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients

Group Type: ACTIVE_COMPARATOR

Conventional angiography-based PCI

Intervention Type: PROCEDURE

Conventional angiography-based PCI

default DAPT regimen

Intervention Type: DRUG

Aspirin and ticagrelor 30 days after DES implantation

Interventions

OCT-guided PCI

OCT-guided PCI based on MLD MAX algorithm

Intervention Type: PROCEDURE

Conventional angiography-based PCI

Conventional angiography-based PCI

Intervention Type: PROCEDURE

DAPT de-escalation

Aspirin and clopidogrel 30 days after DES implantation

Intervention Type: DRUG

default DAPT regimen

Aspirin and ticagrelor 30 days after DES implantation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18 ~ 85 years old adult patients;

2. Patients diagnosed with STEMI and undergoing PCI.

3. Patients able and willing to give written informed consent and to comply with the requirements of this study protocol.

Exclusion Criteria

1. Prior history of intracranial hemorrhage or ischemic stroke during the past 6 months；

2. Allergy to aspirin or clopidogrel or ticagrelor;

3. Occurrence of major adverse cardiovascular event (MACE) within 30 days after undergoing PCI;

4. Platelet count < 50 × 109/L;

5. Major bleeding during the past 12 months;

6. Any form of oral, long-term anticoagulation therapy;

7. Pregnancy or lactation;

8. Suspected aortic dissection;

9. Coronary CT-negative patients;

10. Life expectancy <1 year;

11. Uncontrolled hypertension, systolic blood pressure (SBP) ≥180 mmHg, and/or diastolic blood pressure (DBP) ≥110 mmHg;

12. Comorbid conditions included the presence of any of the following: cardiogenic shock, chronic congestive heart failure with NYHA classes III or IV, left ventricular ejection fraction (LVEF) < 35% at transthoracic echocardiography, hypotension with SBP < 90mmHg and/or DBP < 60mmHg, severe arrhythmia (including high-degree AV block, sick sinus syndrome, sustained ventricular tachycardia), severe pulmonary insufficiency, pulmonary embolism, hepatic insufficiency due to non-cardiac causes (ALT or AST more than three times the upper limit of the institution's normal reference ranges), cirrhosis, severe renal failure (eGFR < 30ml/min/1.73m2);

13. Surgery plan within 30 days;

14. Psychiatric abnormalities or alcohol dependence;

15. Patients who are participating in other clinical trials;

16. Unable to tolerate 1 month of DAPT;

17. Angiographic triple vessel disease coronary disease;

18. Other situations judged by the investigators not to be suitable for the clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shenyang Northern Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han Yaling

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaling Han

Role: PRINCIPAL_INVESTIGATOR

Shenyang Northern Hospital

Locations

Northern Hospital

Shenyang, Liaoning, China

Countries

China

Central Contacts

Yaling Han

Role: CONTACT

cardiology@163.com

86-24-28856123

Facility Contacts

Yaling Han, Dr

Role: primary

cardiology@163.com

+86-24-28897313

References

Ali ZA, Karimi Galougahi K, Thomas SV, Abu-Much A, Chau K, Dakroub A, Shlofmitz ES, Jeremias A, West N, Matsumura M, Mintz GS, Maehara A, Shlofmitz RA. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention: Practical Application. Interv Cardiol Clin. 2023 Apr;12(2):215-224. doi: 10.1016/j.iccl.2022.12.003. Epub 2023 Jan 31.

Reference Type: BACKGROUND

PMID: 36922062 (View on PubMed)

Giugliano RP, Braunwald E. The year in acute coronary syndrome. J Am Coll Cardiol. 2014 Jan 28;63(3):201-14. doi: 10.1016/j.jacc.2013.10.041. Epub 2013 Nov 13. No abstract available.

Reference Type: BACKGROUND

PMID: 24239661 (View on PubMed)

Bliden KP, Tantry US, Storey RF, Jeong YH, Gesheff M, Wei C, Gurbel PA. The effect of ticagrelor versus clopidogrel on high on-treatment platelet reactivity: combined analysis of the ONSET/OFFSET and RESPOND studies. Am Heart J. 2011 Jul;162(1):160-5. doi: 10.1016/j.ahj.2010.11.025. Epub 2011 Jun 12.

Reference Type: BACKGROUND

PMID: 21742103 (View on PubMed)

Capodanno D, Alfonso F, Levine GN, Valgimigli M, Angiolillo DJ. ACC/AHA Versus ESC Guidelines on Dual Antiplatelet Therapy: JACC Guideline Comparison. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2915-2931. doi: 10.1016/j.jacc.2018.09.057.

Reference Type: BACKGROUND

PMID: 30522654 (View on PubMed)

Cuisset T, Deharo P, Quilici J, Johnson TW, Deffarges S, Bassez C, Bonnet G, Fourcade L, Mouret JP, Lambert M, Verdier V, Morange PE, Alessi MC, Bonnet JL. Benefit of switching dual antiplatelet therapy after acute coronary syndrome: the TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study. Eur Heart J. 2017 Nov 1;38(41):3070-3078. doi: 10.1093/eurheartj/ehx175.

Reference Type: BACKGROUND

PMID: 28510646 (View on PubMed)

Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Holdt L, Felix SB, Parma R, Klopotowski M, Schwinger RHG, Rieber J, Huber K, Neumann FJ, Koltowski L, Mehilli J, Huczek Z, Massberg S; TROPICAL-ACS Investigators. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. Lancet. 2017 Oct 14;390(10104):1747-1757. doi: 10.1016/S0140-6736(17)32155-4. Epub 2017 Aug 28.

Reference Type: BACKGROUND

PMID: 28855078 (View on PubMed)

Bonello L, Laine M, Kipson N, Mancini J, Helal O, Fromonot J, Gariboldi V, Condo J, Thuny F, Frere C, Camoin-Jau L, Paganelli F, Dignat-George F, Guieu R. Ticagrelor increases adenosine plasma concentration in patients with an acute coronary syndrome. J Am Coll Cardiol. 2014 Mar 11;63(9):872-7. doi: 10.1016/j.jacc.2013.09.067. Epub 2013 Nov 27.

Reference Type: BACKGROUND

PMID: 24291273 (View on PubMed)

Kim CJ, Park MW, Kim MC, Choo EH, Hwang BH, Lee KY, Choi YS, Kim HY, Yoo KD, Jeon DS, Shin ES, Jeong YH, Seung KB, Jeong MH, Yim HW, Ahn Y, Chang K; TALOS-AMI investigators. Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial. Lancet. 2021 Oct 9;398(10308):1305-1316. doi: 10.1016/S0140-6736(21)01445-8.

Reference Type: BACKGROUND

PMID: 34627490 (View on PubMed)

Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.

Reference Type: BACKGROUND

PMID: 37622654 (View on PubMed)

Other Identifiers

DAPT-OCT

Identifier Type: -

Identifier Source: org_study_id