MARINER

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-005-16
• Date of registration: 20/07/2016
• Prospective Registration: No
• Primary sponsor: Janssen Research & Develoment, LLC,
• Public title: MARINER
• Scientific title: MEDICALLY ILL PATIENT ASSESSMENT OF RIVAROXABAN VERSUS PLACEBO IN REDUCING POST-DISCHARGE VENOUS THROMBO-EMBOLISM RISK (MARINER)
• Date of first enrolment: 15/06/2016
• Target sample size: 100
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=005-16
• Study type: Interventional
• Study design: This is a multicenter, prospective, randomized, double-blind, placebo-controlled, event-driven study designed to evaluate rivaroxaban, compared with placebo, in the prevention of symptomatic VTE (lower extremity DVT and non-fatal PE) events and VTE-related deaths (death due to PE or death in which PE cannot be ruled out as the cause) for a period of 45 days post-hospital discharge. The study consists of a screening phase, a 45-day double-blind treatment phase, and a 30-day safety follow-up period.The subject population comprises men and women age 40 years and older who have completed screening no later than 1 day after leaving the hospital. Subjects who meet all of the inclusion and none of the exclusion criteria will be randomly assigned to receive rivaroxaban or placebo. Randomization should occur on the same day as or the day after the subject leaves the hospital, and may occur at the hospital, clinic or other discharge destination. Subjects will be randomized by strata in
• Phase: III

Countries of recruitment

Argentina, Australia, Austria, Belarus, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Macedonia, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Turkey, Ukraine, United Kindgdom, United States, Yugoslavia

Contacts

• Name: Bertha del Pilar Lavado Cabrera
• Affiliation: PAREXEL INTERNATIONAL (PERU) S.A.

Key inclusion & exclusion criteria

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 PROTOCOL

Age minimum: 40
Age maximum: 90
Gender: --

Health Condition(s) or Problem(s) studied

Embolism and thrombosis of unspecified vein

I269

-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

I829

Pulmonary embolism without mention of acute cor pulmonale

Intervention(s)

Subjects will be randomly assigned to 1 of 2 treatment groups based on a computer-generated randomization schedule prepared before the study under the supervision of the sponsor.Treatment groups in this study are rivaroxaban and placebo. Subjects will be randomly assigned in a 1:1 ratio to receive rivaroxaban 10 mg daily (7.5mg daily in subjects with CrCl of ≥30 and <50 mL/min) or matching placebo daily.All subjects should take study drug (rivaroxaban or placebo) daily with or without food at approximately the same time each day, and discontinue study drug after they take a dose on Day 45. Regardless of the day on which the Day 45 Visit occurs, no study drug may be taken after Day 45.The study drug supplied for this study is rivaroxaban 10 mg, rivaroxaban 7.5mg and matching placebo. All study drugswill be provided as round white tablets.

Source(s) of Monetary Support

Janssen Research and Development LLC

Ethics review

Status: Approved
Approval date: 14/12/2015
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 17/12/2015
Contact:

[e-mail]

Hospital Nacional Dos de Mayo

3280028

[e-mail]

Status: Approved
Approval date: 21/01/2016
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 15/03/2016
Contact:

[e-mail]

Hospital Nacional Arzobispo Loayza

88339014 - 3301677

[e-mail]

Status: Approved
Approval date: 06/04/2016
Contact:

[e-mail]

Hospital Nacional Arzobispo Loayza

88339014 - 3301677

[e-mail]

Status: Approved
Approval date: 12/04/2016
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 29/04/2016
Contact:

[e-mail]

Hospital Nacional Alberto Sabogal Sologuren

4297744 anexo 5388

[e-mail]

Status: Approved
Approval date: 11/05/2016
Contact:

[e-mail]

Hospital Nacional Guillermo Almenara Irigoyen - EsSalud

999436950

[e-mail]

Status: Approved
Approval date: 26/05/2016
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 05/07/2016
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Status: Approved
Approval date: 22/07/2016
Contact:

[e-mail]

Hospital Nacional Guillermo Almenara Irigoyen - EsSalud

999436950

[e-mail]

Status: Approved
Approval date: 10/08/2016
Contact:

[e-mail]

Hospital Nacional Guillermo Almenara Irigoyen - EsSalud

999436950

[e-mail]

Results

• Results available: Yes
• Date Completed: 27/03/2018