NCT06339021Not yet recruitingEarly phase 1
OCT or Angiography Guided De-escalation of DAPT
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 24 Mar 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Shenyang Northern Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06339021
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 80
- From 1 Apr 2024 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of intracranial hemorrhage or ischemic stroke during the past 6 months；
- Any form of oral, long-term anticoagulation therapy;
- Surgery plan within 30 days;
Other illness
- Allergy to aspirin or clopidogrel or ticagrelor;
- Major bleeding during the past 12 months;
- Uncontrolled hypertension, systolic blood pressure (SBP) ≥180 mmHg, and/or diastolic blood pressure (DBP) ≥110 mmHg;
- Psychiatric abnormalities or alcohol dependence;
- Angiographic triple vessel disease coronary disease;
Lab values
- Platelet count \< 50 × 109/L;
- 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);
Other
- Occurrence of major adverse cardiovascular event (MACE) within 30 days after undergoing PCI;
- Pregnancy or lactation;
- Suspected aortic dissection;
- Coronary CT-negative patients;
- Life expectancy \<1 year;
- Patients who are participating in other clinical trials;
- Unable to tolerate 1 month of DAPT;
- Other situations judged by the investigators not to be suitable for the clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northern Hospital Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.