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New treatment option for Coronary Microvascular Dysfunction
Official title A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.
ClinicalTrials.gov ID: NCT05984537
What this study is testing
What is Bivalirudin?
Bivalirudin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for coronary microvascular dysfunction.
Also referred to as bivalirudin anticoagulation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this study, investigators enrolled patients with coronary heart disease who were scheduled to undergo percutaneous coronary intervention (PCI) and had high-risk plaques according to computed tomography angiography (CTA). During the PCI procedure, patients will be randomly assigned to receive either bivalirudin or standard heparin anticoagulation therapy.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- aged 18 years or older;
- diagnosed with non-ST-segment elevation myocardial infarction or unstable angina pectoris;
- scheduled to undergo elective coronary angiography and intervention;
- coronary computed tomography angiography showing high-risk plaque features within 3 months prior to the procedure;
- voluntary participation in the study and signed informed consent.
You likely can't join if
- prior PCI of the target vessel within 3 months;
- cardiogenic shock, active bleeding, bleeding disorders, irreversible coagulation dysfunction, severe liver dysfunction (Child-Pugh class C), severe...
- life expectancy less than 1 year;
- chronic total occlusion of the target vessel;
- poor opacification of the target vessel, severe vessel overlap or distortion, and inability to completely expose the lesion site;
- allergy to contrast agents, verapamil, or its excipients;
See the full eligibility criteria
- aged 18 years or older;
- diagnosed with non-ST-segment elevation myocardial infarction or unstable angina pectoris;
- scheduled to undergo elective coronary angiography and intervention;
- coronary computed tomography angiography showing high-risk plaque features within 3 months prior to the procedure;
- voluntary participation in the study and signed informed consent.
- prior PCI of the target vessel within 3 months;
- cardiogenic shock, active bleeding, bleeding disorders, irreversible coagulation dysfunction, severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (eGFR \< 30 ml/min/1.73m2), and dependence on...
- life expectancy less than 1 year;
- chronic total occlusion of the target vessel;
- poor opacification of the target vessel, severe vessel overlap or distortion, and inability to completely expose the lesion site;
- allergy to contrast agents, verapamil, or its excipients;
- severe uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
- subacute bacterial endocarditis.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.