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New treatment option for STEMI - ST Elevation Myocardial Infarction
Official title Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus
ClinicalTrials.gov ID: NCT06013020
What this study is testing
What is NOAC+DAPT?
NOAC+DAPT is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for stemi - st elevation myocardial infarction.
Also referred to as Rivaroxaban + ticagrelor or clopidogrel + aspirin.
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
- To manage the ST-segment elevation myocardial infarction (STEMI) caused by plaque rupture, triggers platelet activation/aggregation and thrombin generation, requires dual (platelet and coagulation) pathway inhibition. However, triple antithrombotic therapy with standard dual antiplatelet therapy (DAPT) and oral anticoagulant (OAC) in the STEMI setting is a challenge, since that increase in potential risk of bleeding.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Ischemic chest discomfort for at least 30 minutes, with at least 1-mm (0.1-mv) ST-segment elevation in anterior leads on a standard 12-lead...
- Patients provide written informed consent prior to enrollment.
You likely can't join if
- Intracranial, gastrointestinal, or urogenital bleeding within 6 months
- Requiring OAC therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism);
- Bleeding diathesis, thrombocytopenia (platelet \<100,000/mL) or hemoglobin \<10 g/dL, and CRUSADE score-based high bleeding risk
- Hepatic dysfunction (serum liver enzyme\>3 times the normal limit)
- Renal failure (eGFR \<15 ml/min/1.73m2 or requiring dialysis)
- Severe chronic obstructive pulmonary disease
See the full eligibility criteria
- Ischemic chest discomfort for at least 30 minutes, with at least 1-mm (0.1-mv) ST-segment elevation in anterior leads on a standard 12-lead electrocardiogram.
- Patients provide written informed consent prior to enrollment.
- Intracranial, gastrointestinal, or urogenital bleeding within 6 months
- Requiring OAC therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism);
- Bleeding diathesis, thrombocytopenia (platelet \<100,000/mL) or hemoglobin \<10 g/dL, and CRUSADE score-based high bleeding risk
- Hepatic dysfunction (serum liver enzyme\>3 times the normal limit)
- Renal failure (eGFR \<15 ml/min/1.73m2 or requiring dialysis)
- Severe chronic obstructive pulmonary disease
- Severe bradycardia (sick sinus syndrome or high degree atrioventricular block without pacemaker protection)
- Drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and...
- Life expectancy \< 1 year
The study team makes the final eligibility decision.
Where it's taking place
- Zunyi, Guizhou, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zunyi, Guizhou, 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.