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Not yet recruitingNCT06339021Updated Apr 1, 2024

OCT or Angiography Guided De-escalation of DAPT

An Early Phase 1 interventional study of OCT-guided PCI and Conventional angiography-based PCI in Optical Coherence Tomography, Dual Antiplatelet Therapy and Antiplatelet De-escalation, sponsored by Shenyang Northern Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-01.

Sponsored by Shenyang Northern Hospital · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Optical Coherence Tomography
  • Dual Antiplatelet Therapy
  • Antiplatelet De-escalation
  • Neointimal Coverage
  • ST Elevation Myocardial Infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 80 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Shenyang Northern Hospital is the lead sponsor of 42 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    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

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

  • Experimental
    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

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

  • Experimental
    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

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

  • Active comparator
    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

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

Interventions

  • ProcedureOCT-guided PCI

    OCT-guided PCI based on MLD MAX algorithm

  • ProcedureConventional angiography-based PCI

    Conventional angiography-based PCI

  • DrugDAPT de-escalation

    Aspirin and clopidogrel 30 days after DES implantation

  • Drugdefault DAPT regimen

    Aspirin and ticagrelor 30 days after DES implantation

06

What researchers measure

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.

    Time frame: At 12-month follow up after PCI

Secondary outcomes

  1. Major adverse cardiovascular and cerebrovascular events (MACCE)

    Defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization

    Time frame: During 12-month follow up

  2. BARC types 2-5 bleeding

    Defined as all BARC type 2-5 bleeding events

    Time frame: During 12-month follow up

  3. In-stent thrombosis

    In-stent thrombosis was defined as new ST elevation with anginal symptoms or an equivalent due to thrombotic occlusion of the stent placed at the culprit lesion confirmed by coronary angiography during the index hospitalization.

    Time frame: During 12-month follow up

07

Study locations

1 site
  • Northern Hospital
    Shenyang, Liaoning, China
    • Yaling Han, Dr · Contact · cardiology@163.com · +86-24-28897313
    • Yaling Han, MD · Principal investigator
    • Yang Li, MD · Sub investigator
    • Yi Li, MD · Sub investigator
08

References and documents

Publications

  • 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. PubMed 36922062 ↗
  • 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. PubMed 24239661 ↗
  • 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. PubMed 21742103 ↗
  • 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. PubMed 30522654 ↗
  • 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. PubMed 28510646 ↗
  • 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. PubMed 28855078 ↗
  • 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. PubMed 24291273 ↗
  • 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. PubMed 34627490 ↗
  • 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. Erratum In: Eur Heart J. 2024 Apr 1;45(13):1145. doi: 10.1093/eurheartj/ehad870. PubMed 37622654 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06339021
Lead sponsor
Shenyang Northern Hospital
Responsible party
Han Yaling (MD, Shenyang Northern Hospital) — Principal investigator
First posted
Apr 1, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Apr 1, 2024

Study contacts

Yaling Han
Contact
cardiology@163.com
86-24-28856123
Yaling Han
principal investigator · Shenyang Northern Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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