Clinical Trials List
2015-04-01 - 2018-12-31
Phase III
Terminated13
Study ended1
ICD-10I63.40
Cerebral infarction due to embolism of unspecified cerebral artery
ICD-10I63.411
Cerebral infarction due to embolism of right middle cerebral artery
ICD-10I63.412
Cerebral infarction due to embolism of left middle cerebral artery
ICD-10I63.419
Cerebral infarction due to embolism of unspecified middle cerebral artery
ICD-10I63.421
Cerebral infarction due to embolism of right anterior cerebral artery
ICD-10I63.422
Cerebral infarction due to embolism of left anterior cerebral artery
ICD-10I63.429
Cerebral infarction due to embolism of unspecified anterior cerebral artery
ICD-10I63.431
Cerebral infarction due to embolism of right posterior cerebral artery
ICD-10I63.432
Cerebral infarction due to embolism of left posterior cerebral artery
ICD-10I63.439
Cerebral infarction due to embolism of unspecified posterior cerebral artery
ICD-10I63.441
Cerebral infarction due to embolism of right cerebellar artery
ICD-10I63.442
Cerebral infarction due to embolism of left cerebellar artery
ICD-10I63.449
Cerebral infarction due to embolism of unspecified cerebellar artery
ICD-10I63.49
Cerebral infarction due to embolism of other cerebral artery
ICD-9434.11
Cerebral embolism with cerebral infarction
Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate (110 or 150 mg, oral, b.i.d) versus acetylsalicytic acid (100mg oral q.d.) in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS).
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Trial Applicant
Boehringer Ingelheim
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Sponsor
Boehringer Ingelheim
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Yu-Wan Yang Division of Neurology
- Hui-Chun Huang Division of Neurology
- Yuh-Cherng Guo Division of Neurology
- Kang-Hsu Lin Division of Neurology
- Ming-Kuei Lu Division of Neurology
- Wei-Shih Huang Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chi-Hung Liu Division of Neurology
- Cheng-Jiun Shiue Division of Neurology
- KuoLun Huang Division of Neurology
- Yu-Jhih Chang Division of Neurology
- 張寓智 Division of Neurology
- 張庭瑜 Division of Neurology
- 張健宏 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 林志明 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Pi-Shan Sung Division of Neurology
- Po-Tseng Lee Division of Neurology
- Han-Wei Huang Division of Neurology
- 蘇慧真 Division of Neurology
- 謝函潔 Division of Neurology
- Chih-Hung Chen Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳廷耀 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 郭怡真 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 吳孟霓 Division of Neurology
- Chien Fu Chen Division of Neurology
- Lin Ruey-Tay Division of Neurology
The Actual Total Number of Participants Enrolled
3 Study ended
Co-Principal Investigator
- LI-KAI TSAI Division of Neurology
- JYH-MING JIMMY JUANG Division of Neurology
- SHIN-JOE YEH Division of Neurology
- SUNG-CHUN TANG Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• Time to first recurrent stroke (ischemic, hemorrhagic, and unspecified)
Key Secondary efficacy endpoints:
• Ischemic Stroke
• Composite endpoint of nonfatal stroke, nonfatal myocardial infarction (MI) and
cardiovascular death
Other Secondary efficacy endpoints:
• Disabling stroke (modified Rankin scale ≥4, as determined 3 months after recurrent
stroke)
• All cause death
Note: all “time to event” endpoints
Safety endpoints
Primary safety endpoint:
• Time to first major bleed according to ISTH criteria
Other safety endpoints- time to first:
• Intracranial hemorrhage
• Life threatening bleed
• Fatal bleed
• Any bleed
Inclution Criteria
1. Age ≥ 60 years or Age 50-59 years plus at least one of the following additional risk factors for stroke:
a) Mild to moderate symptomatic heart failure, i.e. NYHA Class ≤ 3 with left ventricular
ejection fraction ≤ 40% as documented by e.g. echocardiogram, radionuclide or contrast angiogram in the last 6 months
b) Diabetes mellitus (either type 1 or type 2)
c) Hypertension requiring medical treatment with antihypertensive medication
d) Patent foramen ovale (PFO) with no interventional occlusion planned
e) Prior stroke or TIA (before index stroke)
f) CHA2DS2-VASc score ≥ 3
2. Acute ischemic stroke with an anatomically appropriate brain lesion visualized by neuroimaging (either brain CT* or MRI). The visualized stroke is non-lacunar infarct, i.e. involving the cortex or >1.5 cm
(>2.0 cm if measured on MRI diffusion-weighted images) in largest
diameter if exclusively subcortical. It must have occurred either:
• up to 3 months before enrollment (Modified Rankin Scale ≤3 at randomization)
OR
• up to 6 months before randomization (Modified Rankin Scale ≤3 at randomization)
in selected patients that are ≥ 60 years plus at least one additional risk factor for
recurrent stroke (see stroke risk factors a - f as outlined in Inclusion 1).
3. Arterial imaging or cervical plus TCD ultrasonograpy does not show
extra-cranial or intracranial atherosclerosis with ≥ 50% luminal
stenosis in artery supplying the area of acute ischemia
4. As evidenced by cardiac monitoring for ≥ 24 hours with automated
rhythm detection, there is absence of AF> 6 minutes in duration
(within a 24 hour period, either as single episode or cumulative time of multiple episodes)
5. The patient must be able to give informed consent in accordance with International Conference on Harmonization (ICH) Good
Clinical Practice (GCP) guidelines and local legislation and/or regulations.
Exclusion Criteria
1. Modified Rankin Scale of ≥ 4 at time of randomization or inability to swallow medications
2. Major risk cardioembolic source of embolism, such as:
a. intracardiac thrombus as evidenced by thansthoracic or transesophageal echocardiography,
b. Paroxsysmal, persistent or permanent AF,
c. atrial flutter,
d. prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical),
e. atrial myxoma,
f. other cardiac tumors,
g. moderate or severe mitral stenosis,
h. recent (< 4weeks) MI,
i. valvular vegetations, or
j. infective endocarditis.
3. Any indication that warrants treatment with an anticoagulant as per Investigator`s judgment.
4. History of AF (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved).
5. Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/ vasospasm, drug abuse).
6. Primary intracerebral hemorrhage on qualifying neuroimaging*
7. Conditions associated with increased risk of bleeding* such as:
a) Major* surgery in the previous month (patient may be eligible when one month has passed)
b) Planned surgery or intervention in the next 3 months
c) History of intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding unless the
causative factor has been permanently eliminated or repaired per Investigator judgment (e.g. by surgery)
d) Gastrointestinal hemorrhage within the past six months unless the
cause has been permanently eliminated or repaired per Investigator judgment (e.g. by surgery), or
endoscopically documented gastroduodenal ulcer disease in the previous 30 days
e) Hemorrhagic disorder or bleeding diathesis, e.g. history of thrombocytopenia or platelet count
<100,000/ml at screening, von Willebrand disease, hemophilia A or B or other hereditary bleeding
disorder, history of prolonged bleeding after surgery/intervention).
f) Fibrinolytic agents within 48 hours of study entry
g) Uncontrolled hypertension (SBP>180mmHg and/or DBP>100 mmHg)
8. History of symptomatic nontraumatic intracranial hemorrhage.
9. Renal impairment with estimated CrCl (as calculated by CockcroftGault equation) <30mL/min at screening or where Investigator expects CrCl is likely to drop below 30mL/min during the course of the study.
10. History of hypersensitivity or known contraindication to dabigatran etexilate or ASA.
11. Known requirement for treatment of a concomitant disease (i.e. other than the index ESUS stroke), with ASA (with the exception of optional concomitant medication as provided by the Sponsor for patients with coronary artery disease, see section 4.1.1), clopidogrel, dipyridamole, dipyridamole+ASA, prasugrel, ticagrelor
or ticlopidine at V1, known need for continuous dual antiplatelet therapy after randomization
12. Known requirement for treatment with methotrexate ≥ 15mg/week, systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John’s Wort or any cytotoxic/myelosuppressive therapy.
13. Concomitant disease that increases the risk of an adverse reaction
to study interventions or with life expectancy <6 months (for any reason) per Investigator judgment.
14. Any recent malignancy or radiation therapy (≤ 6 months) unless the malignancy was a basal cell carcinoma that was completely removed.
15. Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who are nursing, pregnant or unwilling to practice an acceptable method of birth control throughout the trial.
16. Patients who have participated in another trial with an investigational drug or device within the past 14 days preceding the screening visit or are participating in another trial assuming no clinical effect from the investigational drug or device used in the previous study remains (patients participating in a purely observational study will not be excluded).
17. Patients considered unreliable by the Investigator concerning the requirements for follow-up during the study or at the end of the study
18. Any condition the Investigator believes would not allow safe participation in the study, e.g. other neurological condition that would complicate assessment of outcomes (e.g. severe dementia).
19. Active liver disease
20. Severe glucose-6-phosphate dehydrogenase deficiency (definition of severe is per investigators judgment)
The Estimated Number of Participants
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Taiwan
130 participants
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Global
6000 participants
