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Dabigatran Following Transient Ischemic Attack and Minor Stroke (DATAS II)

Primary Purpose

Transient Ischemic Attack, Minor Ischemic Stroke

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Dabigatran

Acetylsalicylic acid

About this trial

This is an interventional treatment trial for Transient Ischemic Attack

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients
Must be >18 years of age
Must have TIA or ischemic stroke (NIHSS score <9 - see section 2.7 for further clarification)
Symptom onset is < 72 hours prior to enrollment or Study therapy must initiated within 48 hours of symptom onset (in case where onset time cannot be established, it will be considered to be the time when the patient was lst know to be well
Informed consent must be obtained from either the patient or substitute decision maker (according to local REB policy) prior to any study related procedures being performed
All patients will have a MRI including DWI prior to randomization
DWI lesion volume must be <25ml
Patients without DWI lesions, but a clinical history considered consistent with TIA, determined by the attending physician, can be included

Exclusion Criteria:

Patients with stroke mimics - such as seizures, migraine etc
Patients with contraindications to MRI including metallic implants
Patients with any past sensitivity to gadolinium contrast media will be eligible, but will not undergo PWI or contrast enhanced MRA (both optional sequences)
Patients with renal failure defined as Glomerular Filtration Rate (GFR) < 30 ml/min
Patients deemed, as attending stroke physician, to have any ongoing bleeding risks or unsuitable for dabigatran therapy
Patients with MRI demonstrated additional pathology including arteriovenous malformations, intracranial aneurysms, tumors or abscess, which potentially increase the rise of bleed. Individuals with small incidental leasions, at low risk of bleed such as meningiomas may be included at the discretion of the investigator.
Patients with an acute DWI lesion volume of >25 ml (DWI volume to be estimated using the ABC/2 technique 110)**
Age <18 years
Pregnant or breast feeding women.
Severe dysphagia necessitating naso-gastric (NG) feeding (dabigatran can not be delivered via NG tube)
Planned thrombolysis or endovascular intervention for the index event
Thrombolysis for ischemic stroke within the preceding 7 days
Planned carotid endarterectomy/carotid artery stent within 30 days Note: Carotid Investigations will be completed prior to enrolment. Patients with symptomatic stenoses and a planned carotid procedure will be excluded.
Any history of spontaneous intracranial bleeding
Clear indication for anticoagulation, including atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable state
Co-morbid illness with expected life expectancy of <90 days

Sites / Locations

University of Calgary
University of Alberta
Grey Nuns Hospital
Vancouver Stroke Program
Hamilton Health Sciences
Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dabigatran therapy

Acetylsalicylic Acid thereapy

Arm Description

150 mg BID for 30 days (dose modification - reduced to 110mg BID in patients >80 years of age and/or an eGFR of 30-50 ml/min)

325 mg loading dose then 81 mg/day for 30 days

Outcomes

Primary Outcome Measures

Rate of symptomatic hemorrhagic transformation

The primary endpoint is the rate of symptomatic hemorrhagic transformation (HT), defined as a parenchymal hematoma, which is >30% of the infarcted area on DWI, with substantial space-occupying effect, associated with clinical worsening (≥4 point increase in National Institutes of Health Stroke Scale (NIHSS) score) within 5 weeks of treatment initiation.

Secondary Outcome Measures

Rate of asymtomatic hemorrhagic transformation

Full Information

NCT ID

NCT02295826

First Posted

November 17, 2014

Last Updated

January 28, 2019

Sponsor

University of Alberta

1. Study Identification

Unique Protocol Identification Number

NCT02295826

Brief Title

Dabigatran Following Transient Ischemic Attack and Minor Stroke

Acronym

DATAS II

Official Title

Dabigatran Following Transient Ischemic Attack and Minor Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 18, 2018 (Actual)

Study Completion Date

December 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Alberta

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Rationale: To date, anticoagulant therapy in acute stroke has also been limited by excess hemorrhagic events. The oral anticoagulant dabigatran is a novel agent, which has been shown to be associated with much lower intracranial hemorrhage rates. It has been suggested that this agent may provide the superior benefits of anticoagulation in acute stroke, without the concomitant increase in hemorrhage risk associated with heparin/LMWH or warfarin. Study Design: DATAS II is a randomized, open label blinded endpoint trial. Participants (n=300) with TIA or ischemic stroke (NIHSS score <9) will be enrolled within 48 hours of symptom onset from approximately four (4) health care centres across Canada. All participants will have an MRI with DWI lesion volume < 25 ml. Participants will be randomized 1:1 to treatment with dabigatran for 30 days or ASA 81 mg daily (current standard of care). All stroke patients will initially be screened with a non-contrast CT scan of the brain. The first MRI will be performed within 48 hours of symptom onset. Imaging studies will be repeated at day 30. All patients will be assessed clinically at Day 30 and Day 90. Study Aims: Establish the safety of early anticoagulation with the novel oral anticoagulant dabigatran in acute cerebrovascular syndrome patients. Identify the rate of both symptomatic and asymptomatic hemorrhagic transformation (HT) associated with these treatments. Identify predictors of HT associated with acute dabigatran treatment. Hypothesis: The Investigators hypothesize that symptomatic HT rates in dabigatran and ASA treated patients will not be significantly different. Study outcomes: The primary outcome is the rate of symptomatic hemorrhagic transformation (HT), defined as a parenchymal hematoma, which is >30% of the infarcted area on DWI, with substantial space- occupying effect, associated with clinical worsening (≥4 point increase in National Institutes of Health Stroke Scale (NIHSS) score) within 5 weeks of treatment initiation. The major secondary outcome the rate of asymtomatic HT see on day 30 MRI sequence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transient Ischemic Attack, Minor Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dabigatran therapy

Arm Type

Experimental

Arm Description

150 mg BID for 30 days (dose modification - reduced to 110mg BID in patients >80 years of age and/or an eGFR of 30-50 ml/min)

Arm Title

Acetylsalicylic Acid thereapy

Arm Type

Active Comparator

Arm Description

325 mg loading dose then 81 mg/day for 30 days

Intervention Type

Drug

Intervention Name(s)

Dabigatran

Other Intervention Name(s)

Pradax (Canada)/ Pradaxa (USA and rest of world)

Intervention Description

Dabigatran will be taken bid for 30 days post enrolment. The dose of dabigatran will be based on patient age and renal function.

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic acid

Other Intervention Name(s)

Aspirin

Intervention Description

participants randomized to ASA therapy will be loaded with 325 mg of ASA, followed by 81 mg/day

Primary Outcome Measure Information:

Title

Rate of symptomatic hemorrhagic transformation

Description

Time Frame

within 5 weeks of treatment initiation

Secondary Outcome Measure Information:

Title

Rate of asymtomatic hemorrhagic transformation

Time Frame

day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients Must be >18 years of age Must have TIA or ischemic stroke (NIHSS score <9 - see section 2.7 for further clarification) Symptom onset is < 72 hours prior to enrollment or Study therapy must initiated within 48 hours of symptom onset (in case where onset time cannot be established, it will be considered to be the time when the patient was lst know to be well Informed consent must be obtained from either the patient or substitute decision maker (according to local REB policy) prior to any study related procedures being performed All patients will have a MRI including DWI prior to randomization DWI lesion volume must be <25ml Patients without DWI lesions, but a clinical history considered consistent with TIA, determined by the attending physician, can be included Exclusion Criteria: Patients with stroke mimics - such as seizures, migraine etc Patients with contraindications to MRI including metallic implants Patients with any past sensitivity to gadolinium contrast media will be eligible, but will not undergo PWI or contrast enhanced MRA (both optional sequences) Patients with renal failure defined as Glomerular Filtration Rate (GFR) < 30 ml/min Patients deemed, as attending stroke physician, to have any ongoing bleeding risks or unsuitable for dabigatran therapy Patients with MRI demonstrated additional pathology including arteriovenous malformations, intracranial aneurysms, tumors or abscess, which potentially increase the rise of bleed. Individuals with small incidental leasions, at low risk of bleed such as meningiomas may be included at the discretion of the investigator. Patients with an acute DWI lesion volume of >25 ml (DWI volume to be estimated using the ABC/2 technique 110)** Age <18 years Pregnant or breast feeding women. Severe dysphagia necessitating naso-gastric (NG) feeding (dabigatran can not be delivered via NG tube) Planned thrombolysis or endovascular intervention for the index event Thrombolysis for ischemic stroke within the preceding 7 days Planned carotid endarterectomy/carotid artery stent within 30 days Note: Carotid Investigations will be completed prior to enrolment. Patients with symptomatic stenoses and a planned carotid procedure will be excluded. Any history of spontaneous intracranial bleeding Clear indication for anticoagulation, including atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable state Co-morbid illness with expected life expectancy of <90 days

Facility Information:

Facility Name

University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

Facility Name

University of Alberta

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Grey Nuns Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6L 5X8

Country

Canada

Facility Name

Vancouver Stroke Program

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Hamilton Health Sciences

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 0A6

Country

Canada

Facility Name

Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

32098609

Citation

Butcher KS, Ng K, Sheridan P, Field TS, Coutts SB, Siddiqui M, Gioia LC, Buck B, Hill MD, Miller J, Klahr AC, Sivakumar L, Benavente OR, Hart RG, Sharma M. Dabigatran Treatment of Acute Noncardioembolic Ischemic Stroke. Stroke. 2020 Apr;51(4):1190-1198. doi: 10.1161/STROKEAHA.119.027569. Epub 2020 Feb 26.

Results Reference

derived

PubMed Identifier

28585903

Citation

Ng KH, Sharma M, Benavente O, Gioia L, Field TS, Hill MD, Coutts SB, Butcher K; DATAS-2 Investigators. Dabigatran following acute transient ischemic attack and minor stroke II (DATAS II). Int J Stroke. 2017 Oct;12(8):910-914. doi: 10.1177/1747493017711947. Epub 2017 Jun 6.

Results Reference

derived

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Dabigatran Following Transient Ischemic Attack and Minor Stroke

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