MARINER

Not Applicable

• Conditions: -I829 Embolism and thrombosis of unspecified vein-I269 Pulmonary embolism without mention of acute cor pulmonale; Pulmonary embolism without mention of acute cor pulmonale; Embolism and thrombosis of unspecified vein; I269; I829

• Registration Number: PER-005-16
• Lead Sponsor: Janssen Research & Develoment, LLC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-20
• Study Completion: 2018-03-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 61

Inclusion Criteria

a. Subject must be a man or woman, ≥40 years of age. b. The duration of the index hospitalization must have been at least 3 and no more than 10 consecutive days. c. The reason for the index hospitalization must have been a new diagnosis or exacerbation of 1 of the following medical conditions: (please see the protocol).c The subject must be at increased risk for VTE by the total modified IMPROVE VTE Risk Score (Table 1; modified from Spyropoulos37) assessed at screening and verified at randomization .d Life expectancy of at least 3 months. E Prescribed thromboprophylaxis (according to ACCP guidelines)20 with UFH or LMWH (eg, dalteparin and enoxaparin) not exceeding 15,000 U on any given day for UFH and not exceeding 5,000 U on any given day for LMWH. F. Each subject must sign an informed consent form (ICF)
. .FOR MORE DETAILS PLEASE SEE THE PROTOCOL

Exclusion Criteria

A. Any bleeding (defined as bleeding requiring hospitalization, transfusion, surgical intervention, invasive procedures, occurring in a critical anatomical site, or causing disability) within 3 months prior to randomization or occurring during index hospitalization. BMajor surgery, biopsy of a parenchymal organ, ophthalmic surgery (excluding cataract surgery), or serious trauma (including head trauma) within 4 weeks before randomization. C.Any planned major surgery (see exclusion criterion #2.3) or major invasive diagnostic procedure intended during the duration of the trial.D.Subjects with any known coagulopathy or bleeding diathesis, or an INR >1.5 during the index hospitalization .E.A history of hemorrhagic stroke or any intracranial bleeding at any time in the past, evidence of primary intracranial hemorrhage on CT or magnetic resonance imaging scan of the brain, or clinical presentation consistent with intracranial hemorrhage. This applies as well to subjects hospitalized for ischemic stroke upon randomization.F. Subject has a history of or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (AV) malformation, or aneurysm. G.Active gastroduodenal ulcer, defined as diagnosed within 3 months or currently symptomatic or known AV malformations of the gastrointestinal tract. H.Screening platelet count <75 x 109 cells/L. FOR MORE DETAILS PLEASE SEE THE PROTOCO

Study & Design

• Study Type: Interventional
• Study Design: Not specified