Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus

Launched by ZUNYI MEDICAL COLLEGE · Aug 25, 2023

Keywords

ClinConnect Summary

The Century trial is studying a new approach to prevent the formation of blood clots in the heart after a heart attack known as STEMI (ST-Elevation Myocardial Infarction). In particular, it looks at whether a medication called rivaroxaban, combined with standard treatment for heart attacks, can help reduce the risk of a serious condition called left ventricular thrombus (LVT) without causing excessive bleeding. The study uses a special tool called the Century Clot analyzer to determine if patients are in a "hypercoagulable" state, meaning their blood is likely to clot too easily, and if so, they may receive rivaroxaban twice a day.

To participate in this trial, individuals need to be between 65 and 75 years old and have experienced chest pain for at least 30 minutes, with specific changes on their heart monitor. However, there are certain health conditions that would exclude someone from participating, such as recent bleeding issues or severe liver and kidney problems. If eligible, participants will be closely monitored for any changes in their blood clotting and overall health. This trial is important because it seeks to find a safer and more effective way to prevent blood clots after a heart attack.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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 telithromycin
• • Life expectancy \< 1 year