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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004412-38 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate | Experimental |
| |
| Warfarin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran etexilate | Drug |
| ||
| Warfarin |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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:
| From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period | VTE criterions:
|
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOP Pellegrin | Bordeaux | 33076 | France | |||
| HOP Lariboisière |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33724104 | Derived | Ferro JM, Bendszus M, Jansen O, Coutinho JM, Dentali F, Kobayashi A, Aguiar de Sousa D, Neto LL, Miede C, Caria J, Huisman H, Diener HC; RE-SPECT CVT Study Group. Recanalization after cerebral venous thrombosis. A randomized controlled trial of the safety and efficacy of dabigatran etexilate versus dose-adjusted warfarin in patients with cerebral venous and dural sinus thrombosis. Int J Stroke. 2022 Feb;17(2):189-197. doi: 10.1177/17474930211006303. Epub 2021 Apr 4. | |
| 32972315 |
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All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that they (all participants) met all inclusion/exclusion criteria. Participants were not to be randomised to trial treatment if any one of the specific entry criteria were not met.
This is a randomised, open-label, exploratory trial with blinded endpoint adjudication (PROBE [prospective, randomised, open-label, blinded endpoint] design), 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran Etexilate | Participants were orally treated with Dabigatran etexilate 150 milligram (mg) capsule twice daily for 24 weeks. |
| FG001 | Warfarin | Participants were orally treated with Warfarin 1 mg/3 mg/5 mg tablet, as needed to maintain a target international normalised ratio (INR) of 2.0 - 3.0, once daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2017 | May 31, 2019 |
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|
| 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 | Cerebral venous recanalisation was assessed by imaging and was adjudicated. Occlusion of cerebral veins and sinuses was scored as: 1 = full occlusion; 0 = no occlusion/partial occlusion. This score was applied using the below conventions: Superior sagittal, straight, cavernous sinuses, left and right jugular veins each scored individually as either 0 or 1; Right lateral transverse and sigmoid sinus were scored together, Left lateral transverse and sigmoid sinus were scored together, Superior petrous sinus and inferior petrous sinus were scored together; Deep venous system, Superficial cortical veins, Cerebellar veins were scored as systems. For each patient a total score was calculated at baseline and at EOT and the recanalisation score was calculated as EOT - baseline total scores with conventions as 0 = no cerebral veins or sinuses fully occluded and 11 = all cerebral veins and sinuses fully occluded; the lower the score, the better. | Baseline and week 24 |
| Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period | Major bleeds were defined according to the ISTH definition of a major bleed, as follows:
| 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 | Intracranial haemorrhage (ICH) comprised the subtypes of intracerebral bleeds, subdural bleeds, epidural bleeds and subarachnoid bleeds that were recorded. | 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. | A clinically relevant non-major bleeding event (CRNMBE) was a clinically overt bleed that did not meet the criteria for a major bleed but prompted a clinical response, in that it led to at least 1 of the following: A hospital admission (i.e. overnight stay in the hospital) for bleeding / A physician guided medical or surgical treatment for bleeding / A physician guided change, interruption or discontinuation of trial medication. | 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 | Percentage of participants with major bleeding according to ISTH criteria or CRNMBEs after up to 24 weeks. | 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 | Percentage of participants with any bleeding event after up to 24 weeks where any bleeding event is the sum of all major and non-major bleeding events. | From first administration of trial medication until end of treatment visit, up to 24 weeks. |
| Paris |
| 75475 |
| France |
| Vivantes Netzwerk für Gesundheit GmbH | Berlin | 12351 | Germany |
| Universitätsklinikum Essen AöR | Essen | 45147 | Germany |
| Asklepios Klinik Wandsbek | Hamburg | 22043 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Mazumdar Shaw Medical centre | Bangalore | 560099 | India |
| Nizam's Institute of Medical Sciences | Hyderabad | 500082 | India |
| Caritas Hospital | Kottayam | 686630 | India |
| Magnum Heart Institute | Nashik | 422005 | India |
| All India Institute of Medical Sciences | New Delhi | 110029 | India |
| Sahyadri Speciality Hospital | Pune | 411004 | India |
| ASST di Cremona | Cremona | 26100 | Italy |
| Fondazione Centro San Raffaele del Monte Tabor | Milan | 20132 | Italy |
| Nuovo Ospedale Civile S. Agostino-Estense | Modena | 41126 | Italy |
| A.O. San Camillo Forlanini | Roma | 00152 | Italy |
| Umberto I Pol. di Roma-Università di Roma La Sapienza | Roma | 00161 | Italy |
| A. O. Ospedale Circolo Fond. Macchi | Varese | 21100 | Italy |
| Academisch Medisch Centrum (AMC) | Amsterdam | 1105 AZ | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| University Clinical Center, Gdansk | Gdansk | 80211 | Poland |
| Copernicus Med.Company.Ltd,Hosp.Nicolaus, Gdansk | Gdansk | 80803 | Poland |
| Independent Public Clin.Hospital No.4,Neurol.Dept,Lublin | Lublin | 20-954 | Poland |
| Psychiatry&Neurol.Instit.Interv.Stroke&Cerebrov.Treatm.Cntr | Warsaw | 02-957 | Poland |
| Hospital Fernando Fonseca, EPE | Amadora | 2720-276 | Portugal |
| CHLO, EPE - Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| CHULN, EPE - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar São João,EPE | Porto | 4202-451 | Portugal |
| Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião | Santa Maria da Feira | 4520-211 | Portugal |
| Reg.State Budget Hlthcare,City Hosp#5,Neurology Dept,Barnaul | Barnaul | 656045 | Russia |
| Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan | Kazan' | 420101 | Russia |
| St.Petersb,State Hlthcare Instit. Elisabeth Hosp,Neurol.dept | Saint Petersburg | 195257 | Russia |
| Sverdlovsk Reg.Clin.Hosp.No.1 | Yekaterinburg | 620102 | Russia |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Derived |
| Ferro JM, Coutinho JM, Jansen O, Bendszus M, Dentali F, Kobayashi A, van der Veen B, Miede C, Caria J, Huisman H, Diener HC; RE-SPECT CVT Study Group. Dural Arteriovenous Fistulae After Cerebral Venous Thrombosis. Stroke. 2020 Nov;51(11):3344-3347. doi: 10.1161/STROKEAHA.120.031235. Epub 2020 Sep 25. |
| 31479105 | Derived | Ferro JM, Coutinho JM, Dentali F, Kobayashi A, Alasheev A, Canhao P, Karpov D, Nagel S, Posthuma L, Roriz JM, Caria J, Frassdorf M, Huisman H, Reilly P, Diener HC; RE-SPECT CVT Study Group. Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients With Cerebral Venous Thrombosis: A Randomized Clinical Trial. JAMA Neurol. 2019 Dec 1;76(12):1457-1465. doi: 10.1001/jamaneurol.2019.2764. |
| 29775170 | Derived | Ferro JM, Dentali F, Coutinho JM, Kobayashi A, Caria J, Desch M, Fraessdorf M, Huisman H, Diener HC. Rationale, design, and protocol of a randomized controlled trial of the safety and efficacy of dabigatran etexilate versus dose-adjusted warfarin in patients with cerebral venous thrombosis. Int J Stroke. 2018 Oct;13(7):766-770. doi: 10.1177/1747493018778125. Epub 2018 May 18. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set (TS): The set includes patients who received at least one dose of study medication and were analysed according to the treatment they received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran Etexilate | Participants were orally treated with Dabigatran etexilate 150 milligram (mg) capsule twice daily for 24 weeks. |
| BG001 | Warfarin | Participants were orally treated with Warfarin 1 mg/3 mg/5 mg tablet, as needed to maintain a target international normalised ratio (INR) of 2.0 - 3.0, once daily for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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:
| Full analysis set (FAS): All patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took study medication. This followed the intent-to-treat principle. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks. |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period | VTE criterions:
| FAS, Magnetic resonance imaging (MRI), Computed tomography (CT) | Posted | Number | 95% Confidence Interval | Percentage of participants | From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks. |
| ||||||||||||||||||||||||||||||
| Secondary | Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24 | Cerebral venous recanalisation was assessed by imaging and was adjudicated. Occlusion of cerebral veins and sinuses was scored as: 1 = full occlusion; 0 = no occlusion/partial occlusion. This score was applied using the below conventions: Superior sagittal, straight, cavernous sinuses, left and right jugular veins each scored individually as either 0 or 1; Right lateral transverse and sigmoid sinus were scored together, Left lateral transverse and sigmoid sinus were scored together, Superior petrous sinus and inferior petrous sinus were scored together; Deep venous system, Superficial cortical veins, Cerebellar veins were scored as systems. For each patient a total score was calculated at baseline and at EOT and the recanalisation score was calculated as EOT - baseline total scores with conventions as 0 = no cerebral veins or sinuses fully occluded and 11 = all cerebral veins and sinuses fully occluded; the lower the score, the better. | FAS - Patients with missing/not analysable MRI scan at baseline or end of treatment (EOT) are excluded from the analysis | Posted | Mean | Standard Deviation | Units on scale | Baseline and week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period | Major bleeds were defined according to the ISTH definition of a major bleed, as follows:
| TS | Posted | Number | 95% Confidence Interval | Percentage of participants | From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks. |
|
| |||||||||||||||||||||||||||||
| Secondary | 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 | Intracranial haemorrhage (ICH) comprised the subtypes of intracerebral bleeds, subdural bleeds, epidural bleeds and subarachnoid bleeds that were recorded. | TS - Patients with missing/not analysable MRI scan at baseline or EOT are excluded from the analysis | Posted | Number | 95% Confidence Interval | Percentage of participants | From first administration of trial medication until end of treatment visit, up to 24 weeks. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period. | A clinically relevant non-major bleeding event (CRNMBE) was a clinically overt bleed that did not meet the criteria for a major bleed but prompted a clinical response, in that it led to at least 1 of the following: A hospital admission (i.e. overnight stay in the hospital) for bleeding / A physician guided medical or surgical treatment for bleeding / A physician guided change, interruption or discontinuation of trial medication. | TS | Posted | Number | 95% Confidence Interval | Percentage of participants | From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Bleeding According to ISTH Criteria or CRNMBEs After up to 24 Weeks | Percentage of participants with major bleeding according to ISTH criteria or CRNMBEs after up to 24 weeks. | TS | Posted | Number | 95% Confidence Interval | Percentage of participants | From first administration of trial medication until end of treatment visit, up to 24 weeks. |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Any Bleeding Event After up to 24 Weeks | Percentage of participants with any bleeding event after up to 24 weeks where any bleeding event is the sum of all major and non-major bleeding events. | TS | Posted | Number | 95% Confidence Interval | Percentage of participants | From first administration of trial medication until end of treatment visit, up to 24 weeks. |
|
|
From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
TS
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran Etexilate | Participants were orally treated with Dabigatran etexilate 150 milligram (mg) capsule twice daily for 24 weeks. | 0 | 60 | 8 | 60 | 21 | 60 |
| EG001 | Warfarin | Participants were orally treated with Warfarin 1 mg/3 mg/5 mg tablet, as needed to maintain a target international normalised ratio (INR) of 2.0 - 3.0, once daily for 24 weeks. | 0 | 60 | 6 | 60 | 17 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Severe fever with thrombocytopenia syndrome | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Evans syndrome | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intracranial venous sinus thrombosis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Intestinal haematoma | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| International normalised ratio fluctuation | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2018 | May 31, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Warfarin |
Participants were orally treated with Warfarin 1 mg/3 mg/5 mg tablet, as needed to maintain a target international normalised ratio (INR) of 2.0 - 3.0, once daily for 24 weeks. |
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| Participants |
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