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NCT Number: NCT06339021

OCT or Angiography Guided De-escalation of DAPT

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Northern Hospital

Shenyang, Liaoning, China

Location contact

Yaling Han, Dr

CONTACT

[email protected]

+86-24-28897313

Yaling Han, MD

PRINCIPAL_INVESTIGATOR

Yang Li, MD

SUB_INVESTIGATOR

Yi Li, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 ~ 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.

Exclusion criteria

  • 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;
  • Unable to tolerate 1 month of DAPT;
  • Angiographic triple vessel disease coronary disease;
  • Other situations judged by the investigators not to be suitable for the clinical trial.

Treatment and study plan

OCT-guided PCI

Procedure

OCT-guided PCI based on MLD MAX algorithm

Conventional angiography-based PCI

Procedure

Conventional angiography-based PCI

DAPT de-escalation

Drug

Aspirin and clopidogrel 30 days after DES implantation

default DAPT regimen

Drug

Aspirin and ticagrelor 30 days after DES implantation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. BARC types 2-5 bleeding

    Time frame: During 12-month follow up

    Defined as all BARC type 2-5 bleeding events

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yaling Han

CONTACT

[email protected]

86-24-28856123

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2024
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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