Dabigatran Following Transient Ischemic Attack and Minor Stroke

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02295826
• Date of registration: 17/11/2014
• Prospective Registration: Yes
• Primary sponsor: University of Alberta
• Public title: Dabigatran Following Transient Ischemic Attack and Minor Stroke DATAS II
• Scientific title: Dabigatran Following Transient Ischemic Attack and Minor Stroke
• Date of first enrolment: January 2015
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02295826
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment.
• Phase: Phase 2

Countries of recruitment

Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female patients

2. Must be >18 years of age

3. Must have TIA or ischemic stroke (NIHSS score <9 - see section 2.7 for further
clarification)

4. 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

5. 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

6. All patients will have a MRI including DWI prior to randomization

7. DWI lesion volume must be <25ml

8. Patients without DWI lesions, but a clinical history considered consistent with TIA,
determined by the attending physician, can be included

Exclusion Criteria:

1. Patients with stroke mimics - such as seizures, migraine etc

2. Patients with contraindications to MRI including metallic implants

3. Patients with any past sensitivity to gadolinium contrast media will be eligible, but
will not undergo PWI or contrast enhanced MRA (both optional sequences)

4. Patients with renal failure defined as Glomerular Filtration Rate (GFR) < 30 ml/min

5. Patients deemed, as attending stroke physician, to have any ongoing bleeding risks or
unsuitable for dabigatran therapy

6. 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.

7. Patients with an acute DWI lesion volume of >25 ml (DWI volume to be estimated using
the ABC/2 technique 110)**

8. Age <18 years

9. Pregnant or breast feeding women.

10. Severe dysphagia necessitating naso-gastric (NG) feeding (dabigatran can not be
delivered via NG tube)

11. Planned thrombolysis or endovascular intervention for the index event

12. Thrombolysis for ischemic stroke within the preceding 7 days

13. 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.

14. Any history of spontaneous intracranial bleeding

15. Clear indication for anticoagulation, including atrial fibrillation, mechanical
cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable
state

16. Co-morbid illness with expected life expectancy of <90 days



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Minor Ischemic Stroke

Transient Ischemic Attack

Intervention(s)

Drug: Dabigatran

Drug: Acetylsalicylic acid

Primary Outcome(s)

Rate of symptomatic hemorrhagic transformation [Time Frame: within 5 weeks of treatment initiation]

Secondary Outcome(s)

Rate of asymtomatic hemorrhagic transformation [Time Frame: day 30]

Secondary ID(s)

DATAS002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors