--- title: A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT) nct_id: NCT02913326 overall_status: COMPLETED phase: PHASE3 sponsor: Boehringer Ingelheim study_type: INTERVENTIONAL primary_condition: Thromboembolism countries: France, Germany, India, Italy, Netherlands, Poland, Portugal, Russia, Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02913326.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02913326" ct_last_update_post_date: 2019-08-15 last_seen_at: "2026-05-12T07:32:50.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT) **Official Title:** RE-SPECT CVT: a Randomised, Open-label, Exploratory Trial With Blinded Endpoint Adjudication (PROBE), Comparing Efficacy and Safety of Oral Dabigatran Etexilate Versus Oral Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis Over a 24-week Period **NCT ID:** [NCT02913326](https://clinicaltrials.gov/study/NCT02913326) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 120 - **Lead Sponsor:** Boehringer Ingelheim - **Conditions:** Thromboembolism - **Start Date:** 2016-12-13 - **Completion Date:** 2018-06-22 - **CT.gov Last Update:** 2019-08-15 ## Brief Summary This is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. This phase III study is planned to investigate the efficacy and safety of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with blinded endpoint adjudication. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 78 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion criteria: * Written informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations * Confirmed diagnosis of Cerebral Venous or dural sinus thrombosis (CVT), with or without intracranial haemorrhage * Completion of anticoagulation therapy for 5-15 days which has been administered until randomisation; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin * Eligibility for treatment with an oral anticoagulant * Further inclusion criteria apply Exclusion criteria: * Cerebral Venous or dural sinus thrombosis (CVT) associated with central nervous system infection or due to head trauma * Planned surgical treatment for CVT * Conditions associated with increased risk of bleeding * History of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence according to Investigator judgment * Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis without change in the regimen * Severe renal impairment * Active liver disease * Pregnancy, nursing or planning to become pregnant while in the trial * Further exclusion criteria apply ``` ## Arms - **Dabigatran etexilate** (EXPERIMENTAL) - **Warfarin** (ACTIVE_COMPARATOR) ## Interventions - **Dabigatran etexilate** (DRUG) - **Warfarin** (DRUG) ## Primary Outcomes - **Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period.** _(time frame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.)_ — Composite of the percentage of participants with MBE according to ISTH criteria and VTE (recurring cerebral venous thrombosis (CVT); deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), splanchnic vein thrombosis) in full observation period. All components were adjudicated in a blinded manner. Major bleeds were defined according to the ISTH definition of a major bleed, as follows: * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or * Bleeding associated with a reduction in haemoglobin of at least 2 grams/deciLitre (1.24 millimole/Litre) within 24 h, or leading to transfusion of 2 or more units of blood or packed cells and/or * Fatal bleed ## Secondary Outcomes - **Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period** _(time frame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.)_ - **Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24** _(time frame: Baseline and week 24)_ - **Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period** _(time frame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.)_ - **Composite Endpoint of Percentage of Participants With New Intracranial Haemorrhage or Worsening of the Haemorrhagic Component of a Previous Lesion After up to 24 Weeks** _(time frame: From first administration of trial medication until end of treatment visit, up to 24 weeks.)_ - **Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period.** _(time frame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.)_ - **Percentage of Participants With Major Bleeding According to ISTH Criteria or CRNMBEs After up to 24 Weeks** _(time frame: From first administration of trial medication until end of treatment visit, up to 24 weeks.)_ - **Percentage of Participants With Any Bleeding Event After up to 24 Weeks** _(time frame: From first administration of trial medication until end of treatment visit, up to 24 weeks.)_ ## Locations (36) - HOP Pellegrin, Bordeaux, France - HOP Lariboisière, Paris, France - Vivantes Netzwerk für Gesundheit GmbH, Berlin, Germany - Universitätsklinikum Essen AöR, Essen, Germany - Asklepios Klinik Wandsbek, Hamburg, Germany - Universitätsklinikum Heidelberg, Heidelberg, Germany - Universitätsklinikum Tübingen, Tübingen, Germany - Mazumdar Shaw Medical centre, Bangalore, India - Nizam's Institute of Medical Sciences, Hyderabad, India - Caritas Hospital, Kottayam, India - Magnum Heart Institute, Nashik, India - All India Institute of Medical Sciences, New Delhi, India - Sahyadri Speciality Hospital, Pune, India - ASST di Cremona, Cremona, Italy - Fondazione Centro San Raffaele del Monte Tabor, Milan, Italy - Nuovo Ospedale Civile S. Agostino-Estense, Modena, Italy - A.O. San Camillo Forlanini, Roma, Italy - Umberto I Pol. di Roma-Università di Roma La Sapienza, Roma, Italy - A. O. Ospedale Circolo Fond. Macchi, Varese, Italy - Academisch Medisch Centrum (AMC), Amsterdam, Netherlands - Universitair Medisch Centrum Utrecht, Utrecht, Netherlands - University Clinical Center, Gdansk, Gdansk, Poland - Copernicus Med.Company.Ltd,Hosp.Nicolaus, Gdansk, Gdansk, Poland - Independent Public Clin.Hospital No.4,Neurol.Dept,Lublin, Lublin, Poland - Psychiatry&Neurol.Instit.Interv.Stroke&Cerebrov.Treatm.Cntr, Warsaw, Poland - Hospital Fernando Fonseca, EPE, Amadora, Portugal - CHLO, EPE - Hospital Egas Moniz, Lisbon, Portugal - CHULN, EPE - Hospital de Santa Maria, Lisbon, Portugal - Centro Hospitalar São João,EPE, Porto, Portugal - Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião, Santa Maria da Feira, Portugal - Reg.State Budget Hlthcare,City Hosp#5,Neurology Dept,Barnaul, Barnaul, Russia - Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan, Kazan', Russia - St.Petersb,State Hlthcare Instit. Elisabeth Hosp,Neurol.dept, Saint Petersburg, Russia - Sverdlovsk Reg.Clin.Hosp.No.1, Yekaterinburg, Russia - Hospital Ramón y Cajal, Madrid, Spain - Hospital La Paz, Madrid, Spain ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.hop pellegrin|bordeaux||france` — added _(2026-05-12)_ - `locations.hop lariboisière|paris||france` — added _(2026-05-12)_ - `locations.vivantes netzwerk für gesundheit gmbh|berlin||germany` — added _(2026-05-12)_ - `locations.universitätsklinikum essen aör|essen||germany` — added _(2026-05-12)_ - `locations.asklepios klinik wandsbek|hamburg||germany` — added _(2026-05-12)_ - `locations.universitätsklinikum heidelberg|heidelberg||germany` — added _(2026-05-12)_ - `locations.universitätsklinikum tübingen|tübingen||germany` — added _(2026-05-12)_ - `locations.mazumdar shaw medical centre|bangalore||india` — added _(2026-05-12)_ - `locations.nizam's institute of medical sciences|hyderabad||india` — added _(2026-05-12)_ - `locations.caritas hospital|kottayam||india` — added _(2026-05-12)_ - `locations.magnum heart institute|nashik||india` — added _(2026-05-12)_ - `locations.all india institute of medical sciences|new delhi||india` — added _(2026-05-12)_ - `locations.sahyadri speciality hospital|pune||india` — added _(2026-05-12)_ - `locations.asst di cremona|cremona||italy` — added _(2026-05-12)_ - `locations.fondazione centro san raffaele del monte tabor|milan||italy` — added _(2026-05-12)_ - `locations.nuovo ospedale civile s. agostino-estense|modena||italy` — added _(2026-05-12)_ - `locations.a.o. san camillo forlanini|roma||italy` — added _(2026-05-12)_ - `locations.umberto i pol. di roma-università di roma la sapienza|roma||italy` — added _(2026-05-12)_ - `locations.a. o. ospedale circolo fond. macchi|varese||italy` — added _(2026-05-12)_ - `locations.academisch medisch centrum (amc)|amsterdam||netherlands` — added _(2026-05-12)_ - `locations.universitair medisch centrum utrecht|utrecht||netherlands` — added _(2026-05-12)_ - `locations.university clinical center, gdansk|gdansk||poland` — added _(2026-05-12)_ - `locations.copernicus med.company.ltd,hosp.nicolaus, gdansk|gdansk||poland` — added _(2026-05-12)_ - `locations.independent public clin.hospital no.4,neurol.dept,lublin|lublin||poland` — added _(2026-05-12)_ - `locations.psychiatry&neurol.instit.interv.stroke&cerebrov.treatm.cntr|warsaw||poland` — added _(2026-05-12)_ - `locations.hospital fernando fonseca, epe|amadora||portugal` — added _(2026-05-12)_ - `locations.chlo, epe - hospital egas moniz|lisbon||portugal` — added _(2026-05-12)_ - `locations.chuln, epe - hospital de santa maria|lisbon||portugal` — added _(2026-05-12)_ - `locations.centro hospitalar são joão,epe|porto||portugal` — added _(2026-05-12)_ - `locations.centro hospitalar de entre o douro e vouga, e.p.e. - hospital de são sebastião|santa maria da feira||portugal` — added _(2026-05-12)_ - `locations.reg.state budget hlthcare,city hosp#5,neurology dept,barnaul|barnaul||russia` — added _(2026-05-12)_ - `locations.interreg. clinical & diagnostic center, neurol. dept., kazan|kazan'||russia` — added _(2026-05-12)_ - `locations.st.petersb,state hlthcare instit. elisabeth hosp,neurol.dept|saint petersburg||russia` — added _(2026-05-12)_ - `locations.sverdlovsk reg.clin.hosp.no.1|yekaterinburg||russia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02913326.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02913326* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*