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Also known as JNJ-70033093, BMS-986177
Milvexian · 4 trials · 4 indications
Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported.
Time to first occurrence of any component of MACE will be reported. MACE is a composite of cardiovascular (CV) death, myocardial infarction (MI), and ischemic stroke.
Time to first occurrence of ischemic stroke will be reported.
Total VTE was defined as the composite of clinical events committee (CEC)-adjudicated proximal and/or distal Deep Vein Thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death.
| Arm | Type | Description |
|---|---|---|
| Milvexian | EXPERIMENTAL | Participants will receive milvexian 100 milligrams (mg) orally, twice daily and placebo that matches apixaban beginning on Day 1 through end of treatment (EOT). Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply. |
| Apixaban | ACTIVE_COMPARATOR | Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply. |
| Placebo | PLACEBO_COMPARATOR | Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator will receive placebo orally, twice daily. |
| Group A: JNJ-70033093 25 mg + Placebo BID | EXPERIMENTAL | Participants will receive JNJ-70033093 25 milligram (mg) (1\*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days. |
| Group B: JNJ-70033093 50 mg BID | EXPERIMENTAL | Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days. |
| Group C: JNJ-70033093 100 mg + Placebo BID | EXPERIMENTAL | Participants will receive JNJ-70033093 100 mg (1\*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days. |
| Group D: JNJ-70033093 200 mg BID | EXPERIMENTAL | Participants will receive JNJ-70033093 200 mg (2\*100 mg capsules) BID orally for 10 to 14 postoperative days. |
| Group E: JNJ-70033093 25 mg Once Daily + Placebo | EXPERIMENTAL | Participants will receive JNJ-70033093 25 mg (1\*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days. |
| Group F: JNJ-70033093 200 mg Once Daily + Placebo | EXPERIMENTAL | Participants will receive JNJ-70033093 200 mg (2\*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days. |
| Group G: JNJ-70033093 50 mg once daily + Placebo | EXPERIMENTAL | Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days. |
| Group I: Enoxaparin 40 mg Once Daily | ACTIVE_COMPARATOR | Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days. |
| Name | Type | Description |
|---|---|---|
| Milvexian | DRUG | Milvexian will be administered orally. |
| Apixaban | DRUG | Apixaban will be administered orally. |
| Placebo | DRUG | Milvexian matching milvexian placebo will be administered orally. |
| Apixaban Placebo | DRUG | Apixaban matching apixaban placebo will be administered orally. |
| JNJ-70033093 25 mg | DRUG | Participants will receive JNJ-70033093 25 mg (1\*25 mg capsule) BID (in Group A) or once daily (in Group E), orally for 10 to 14 postoperative days. |
| JNJ-70033093 50 mg | DRUG | Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days. |
| JNJ-70033093 100 mg | DRUG | Participants will receive JNJ-70033093 100 mg (1\*100 mg capsule) BID, orally for 10 to 14 postoperative days. |
| JNJ-70033093 200 mg | DRUG | Participants will receive JNJ-70033093 200 mg (2\*100 mg capsules) BID (in Group D) or once daily (in Group F), orally for 10 to 14 postoperative days. |
| Enoxaparin 40 mg | DRUG | Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days. |
Inclusion Criteria: * Minimum age of 18 years * Medically stable and appropriate for chronic antithrombotic treatment * Atrial fibrillation eligible to receive anticoagulation * Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the followin...
Milvexian is an investigational small molecule anticoagulant being developed by Johnson & Johnson for cardiovascular conditions. It is a Factor XI (F11) inhibitor and is in Phase 3 clinical development for acute coronary syndrome, atrial fibrillation, and ischemic stroke or high-risk transient ischemic attack. It is not approved for any indication.
Milvexian targets Factor XI, also known as F11. It is a small molecule inhibitor of this clotting factor, which is part of the coagulation cascade. Inhibiting Factor XI is being studied as an approach to reduce clot formation in cardiovascular conditions such as atrial fibrillation, acute coronary syndrome, and ischemic stroke.
Milvexian is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is running the Phase 3 clinical program for the drug across several cardiovascular indications, including atrial fibrillation, acute coronary syndrome, and ischemic stroke or transient ischemic attack.
Milvexian is in Phase 3 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The Phase 3 program includes trials in atrial fibrillation, acute coronary syndrome, and ischemic stroke or high-risk transient ischemic attack.
Milvexian is being studied in three Phase 3 trials. NCT05757869 compares milvexian with apixaban in atrial fibrillation and enrolled 20,284 participants. NCT05754957 studied milvexian after recent acute coronary syndrome and enrolled 14,194 participants. NCT05702034, called LIBREXIA-STROKE, studied milvexian after acute ischemic stroke or high-risk transient ischemic attack and enrolled 12,523 participants.
Milvexian is being studied for cardiovascular conditions including atrial fibrillation, acute coronary syndrome, and ischemic stroke or high-risk transient ischemic attack. It is an investigational Factor XI inhibitor in Phase 3 development and is not currently approved for use in any of these indications.