OCT or Angiography Guided De-escalation of DAPT

March 24, 2024 updated by: Han Yaling, Shenyang Northern Hospital

Evaluation of Neointimal Coverage After Guiding De-escalation of Antiplatelet Treatment in Patients With ST-elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention by Optical Coherence Tomography or Angiography of STEMI Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • Northern Hospital
        • Principal Investigator:
          • Yaling Han, MD
        • Sub-Investigator:
          • Yi Li, MD
        • Contact:
        • Sub-Investigator:
          • Yang Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
OCT-guided PCI based on MLD MAX algorithm
Drug: DAPT de-escalation
Aspirin and clopidogrel 30 days after DES implantation
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
OCT-guided PCI based on MLD MAX algorithm
Drug: default DAPT regimen
Aspirin and ticagrelor 30 days after DES implantation
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
Drug: DAPT de-escalation
Aspirin and clopidogrel 30 days after DES implantation
Procedure: Conventional angiography-based PCI
Conventional angiography-based PCI
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
Drug: default DAPT regimen
Aspirin and ticagrelor 30 days after DES implantation
Procedure: Conventional angiography-based PCI
Conventional angiography-based PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neointimal thickness after DES implantation
Time Frame: At 12-month follow up after PCI
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time Frame: During 12-month follow up
Defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization
During 12-month follow up
BARC types 2-5 bleeding
Time Frame: During 12-month follow up
Defined as all BARC type 2-5 bleeding events
During 12-month follow up
In-stent thrombosis
Time Frame: During 12-month follow up
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.
During 12-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Northern Hospital

Investigators

  • Principal Investigator: Yaling Han, Shenyang Northern Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

March 24, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAPT-OCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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