Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2013-003444-24-SE |
Date of registration:
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29/09/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Dabigatran etexilate for Secondary Stroke Prevention in Patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
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Scientific title:
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Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate (110 mg or 150 mg, oral b.i.d.) versus acetylsalicylic acid (100 mg oral q.d.) in patients with Embolic Stroke of Undetermined Source (RESPECT ESUS) - RESPECT ESUS |
Date of first enrolment:
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13/11/2014 |
Target sample size:
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6750 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003444-24 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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Chile
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China
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Colombia
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Croatia
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Czech Republic
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Estonia
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European Union
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France
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Germany
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Greece
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Hong Kong
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Hungary
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India
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Italy
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Japan
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Korea, Republic of
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Mexico
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New Zealand
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Peru
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Poland
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Portugal
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Russian Federation
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Serbia
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Singapore
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Slovakia
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Slovenia
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Spain
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Sweden
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Switzerland
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Taiwan
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Thailand
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United States
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Contacts
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Name:
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QRPE PSC CT Information Disclosure
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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1 8002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim Pharma GmbH |
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Name:
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QRPE PSC CT Information Disclosure
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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1 8002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim Pharma GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) Age greater than or equal to 60 years
or:
Age 50 to 59 years plus at least one of the following additional risk factors for stroke:
a) Mild to moderate heart failure, i.e. New York Heart Association (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 with no interventional occlusion planned
e) Prior stroke or Transient Ischemic Attach (TIA) (before index stroke)
f) CHA2DS2-VASc (Congestive heart failure, Hypertension, Age >=75, Diabetes, prior Stroke/Transient Ischemic Attack) 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:
a. up to 3 months before randomization (Modified Rankin Scale (mRS) <=3 at randomization)
OR
b. up to 6 months before randomization mRS <=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 transcranial doppler (TCD) ultrasonography 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 atrial fibrillation (AF) > 6 minutes in duration (within a 24 hour period, either as single episode or cumulative time of multiple episodes).
5) The patient must give informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations.
Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3600
Exclusion criteria: 1. Modified Rankin Scale of >=4 at time of rand. or inability to swallow medications.
2. Major risk cardioembolic source of embolism such as:
a.intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography,
b.paroxysmal, 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 requires treatment with an anticoagulant as per Investigator`s judgment.
4. History of AF (unless it was due to reversible causes 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 (in which case the patient may be eligible when one month has passed)
b) Planned major 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 Systolic Blood Pressure (SBP) >180mmHg and/or Diastolic Blood Pressure (DBP) >100 mmHg)
8. History of symptomatic nontraumatic intracranial hemorrhage.
9. Renal impairment with estimated CrCl (as calculated by Cockcroft-Gault 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 (DE) or ASA.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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A study to compare dabigatran etexilate to acetylsalicylic acid in preventing recurrent stroke for patients that already had a stroke caused by an embolus (clot). Despite testing, it is unknown where in the body the embolus developed. MedDRA version: 17.0
Level: PT
Classification code 10067167
Term: Cerebellar embolism
System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0
Level: PT
Classification code 10014498
Term: Embolic stroke
System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0
Level: PT
Classification code 10060839
Term: Embolic cerebral infarction
System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0
Level: PT
Classification code 10074422
Term: Brain stem embolism
System Organ Class: 10029205 - Nervous system disorders
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Intervention(s)
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Trade Name: Pradaxa Product Name: dabigatran etexilate 110 mg Product Code: BIBR 1048 MS Pharmaceutical Form: Capsule, hard INN or Proposed INN: dabigatran etexilate Current Sponsor code: BIBR 1048 MS Other descriptive name: DABIGATRAN ETEXILATE MESILATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 110- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Trade Name: Pradaxa Product Name: dabigatran etexilate 150 mg Product Code: BIBR 1048 MS Pharmaceutical Form: Capsule, hard INN or Proposed INN: dabigatran etexilate Current Sponsor code: BIBR 1048 MS Other descriptive name: DABIGATRAN ETEXILATE MESILATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Trade Name: ASS 100 mg Product Name: ASS 100 mg Pharmaceutical Form: Tablet INN or Proposed INN: acetylsalicylic acid Other descriptive name: ACETYLSALICYLIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100 - Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Time to first recurrent stroke (ischemic, hemorrhagic, or unspecified)
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Main Objective: To compare the efficacy of dabigatran etexilate (110 mg b.i.d. or 150 mg b.i.d., with dosing according to age and renal function), to ASA (100 mg once daily) for the prevention of stroke recurrence in patients with embolic stroke of undetermined source.
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Secondary Objective: The trial will also characterize the safety of dabigatran etexilate in this setting.
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Timepoint(s) of evaluation of this end point: up to 36 months
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Secondary Outcome(s)
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Secondary end point(s): 1: Time to first major bleed
2: Time to Ischemic Stroke
3: Composite endpoint of (time to) nonfatal stroke, nonfatal myocardial infarction (MI) and cardiovascular death
4: Time to Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke)
5: Time to All-cause death
6: Time to first intracranial hemorrhage
7: Time to life-threatening bleed
8: Fatal bleed
9: Time to any bleed (all severities)
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Timepoint(s) of evaluation of this end point: 1: up to 36 months
2: up to 36 months
3: up to 36 months
4: up to 36 months
5: up to 36 months
6: up to 36 months
7: up to 36 months
8: up to 36 months
9: up to 36 months
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Secondary ID(s)
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2013-003444-24-PT
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1160.189
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Source(s) of Monetary Support
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Boehringer Ingelheim Pharma GmbH
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Ethics review
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Status: Approved
Approval date:
Contact:
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