OCT or Angiography Guided De-escalation of DAPT

NCT06339021 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: DAPT-OCT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Neointimal thickness after DES implantation

  Stent and luminal cross-sectional areas (CSAs) were measured. Neointimal CSA was calculated as stent CSA minus lumen CSA. Neointimal thickness was measured as the distance between endoluminal surface of neointima and strut, which was obtained at 12-month follow-up.

  At 12-month follow up after PCI

Secondary Outcomes (3)

• Major adverse cardiovascular and cerebrovascular events (MACCE)

  During 12-month follow up

• BARC types 2-5 bleeding

  During 12-month follow up

• In-stent thrombosis

  During 12-month follow up

Study Arms (4)

OCT-guided PCI and DAPT De-escalation

EXPERIMENTAL

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

Procedure: OCT-guided PCI; Drug: DAPT de-escalation

OCT-guided PCI and default DAPT regimen

EXPERIMENTAL

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

Procedure: OCT-guided PCI; Drug: default DAPT regimen

Conventional angiography-based PCI and DAPT De-escalation

EXPERIMENTAL

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

Procedure: Conventional angiography-based PCI; Drug: DAPT de-escalation

Conventional angiography-based PCI and default DAPT regimen

ACTIVE COMPARATOR

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

Procedure: Conventional angiography-based PCI; Drug: default DAPT regimen

Interventions

OCT-guided PCI PROCEDURE

OCT-guided PCI based on MLD MAX algorithm

OCT-guided PCI and DAPT De-escalation; OCT-guided PCI and default DAPT regimen

Conventional angiography-based PCI PROCEDURE

Conventional angiography-based PCI

Conventional angiography-based PCI and DAPT De-escalation; Conventional angiography-based PCI and default DAPT regimen

DAPT de-escalation DRUG

Aspirin and clopidogrel 30 days after DES implantation

Conventional angiography-based PCI and DAPT De-escalation; OCT-guided PCI and DAPT De-escalation

default DAPT regimen DRUG

Aspirin and ticagrelor 30 days after DES implantation

Conventional angiography-based PCI and default DAPT regimen; OCT-guided PCI and default DAPT regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~ 85 years old adult patients;
• Patients diagnosed with STEMI and undergoing PCI.
• Patients able and willing to give written informed consent and to comply with the requirements of this study protocol.

You may not qualify if:

• Prior history of intracranial hemorrhage or ischemic stroke during the past 6 months；
• Allergy to aspirin or clopidogrel or ticagrelor;
• Occurrence of major adverse cardiovascular event (MACE) within 30 days after undergoing PCI;
• Platelet count \< 50 × 109/L;
• Major bleeding during the past 12 months;
• Any form of oral, long-term anticoagulation therapy;
• Pregnancy or lactation;
• Suspected aortic dissection;
• Coronary CT-negative patients;
• Life expectancy \<1 year;
• Uncontrolled hypertension, systolic blood pressure (SBP) ≥180 mmHg, and/or diastolic blood pressure (DBP) ≥110 mmHg;
• 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);
• Surgery plan within 30 days;
• Psychiatric abnormalities or alcohol dependence;
• Patients who are participating in other clinical trials;

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

Northern Hospital

Shenyang, Liaoning, China

Location

Related Publications (9)

• 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.

  PMID: 36922062 BACKGROUND

• 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.

  PMID: 24239661 BACKGROUND

• 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.

  PMID: 21742103 BACKGROUND

• 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.

  PMID: 30522654 BACKGROUND

• 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.

  PMID: 28510646 BACKGROUND

• 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.

  PMID: 28855078 BACKGROUND

• 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.

  PMID: 24291273 BACKGROUND

• 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.

  PMID: 34627490 BACKGROUND

• 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.

  PMID: 37622654 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Yaling Han

  Shenyang Northern Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaling Han

CONTACT

86-24-28856123; cardiology@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)