THrombolysis for Acute Wake-up and Unclear-onset Strokes With Alteplase at 0.6 mg/kg Trial (THAWS) (THAWS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02002325 |
Recruitment Status
:
Recruiting
First Posted
: December 5, 2013
Last Update Posted
: April 2, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke | Drug: Tissue-type plasminogen activator (alteplase) Other: Standard care | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | THrombolysis for Acute Wake-up and Unclear-onset Strokes With Alteplase at 0.6 mg/kg Trial (THAWS) |
Actual Study Start Date : | May 2014 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | March 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Alteplase
Intravenous tissue-type plasminogen activator (alteplase)
|
Drug: Tissue-type plasminogen activator (alteplase)
Intravenous tissue-type plasminogen activator (alteplase) 0.6mg/kg body-weight up to a maximum of 60 mg, 10% as bolus, 90% over 1 hour as infusion (plus other standard treatment if needed)
Other Names:
|
Standard Care
Standard treatment for acute stroke
|
Other: Standard care
Standard treatment for acute stroke without intravenous alteplase.
|
- Modified Rankin Scale 0-1 [ Time Frame: 90 days after stroke ]
- Categorical shift in National Institutes of Health (NIHSS) score from baseline [ Time Frame: 24 hours after stroke ]
- Categorical shift in NIHSS score from baseline [ Time Frame: 7 days after stroke ]
- Modified Rankin Scale 0-2 [ Time Frame: 90 days after stroke ]
- Categorical shift in modified Rankin Scale score from baseline [ Time Frame: 90 days after stroke ]
- Symptomatic intracranial hemorrhage (sICH) in SITS-MOST [ Time Frame: 24 hours after treatment ]MRI proven SICH
- sICH as defined in European Cooperative Acute Stroke Study (ECASS) II [ Time Frame: 24 hours after stroke ]MRI proven SICH
- sICH as defined in National Institute of Neurological Disorders and Stroke (NINDS) [ Time Frame: 24 hours after stroke ]MRI proven SICH
- Parenchymal hemorrhage type-2 (PH-2) [ Time Frame: 24 hours after stroke ]MRI proven SICH
- Major bleeding [ Time Frame: Up to 90 days after stroke ]Fatal bleeding, symptomatic bleeding in a critical area or organ, such as intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, or bleeding causing a fall in hemoglobin level of ≥2g/dL, or leading to transfusion of ≥4.5 units of whole blood or red cells according to the definition of the International Society on Thrombosis and Haemostasis
- Modified Rankin Scale 6 [ Time Frame: 90 days after stroke ]Death due to any cause

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of acute ischemic stroke with unknown symptom onset (e.g. acute wake-up ischemic stroke, acute ischemic stroke with unknown time of symptom onset)
- Last known well without neurological symptoms >4.5 hours of treatment initiation
- Treatment can be started within 4.5 hours of symptom recognition (e.g. awaking)
- Acute stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) completed
- Alberta Stroke Program Early CT score (ASPECTS) on initial DWI is 5 or more
- No marked parenchymal hyperintensity visible on FLAIR
- Initial NIHSS ≥2
- Written informed consent by patient or next of kin
Exclusion Criteria:
- Pre-stroke Modified Rankin Scale (mRS) >1 (patients who have inability to carry out all daily activities and require some help or supervision)
-
Contraindications in the Japanese guideline for the intravenous application of recombinant tissue-type plasminogen activator (alteplase)
- History of nontraumatic intracranial hemorrhage
- History of stroke within the last 1 month (excluding transient ischemic attack)
- History of significant head/spinal injury or surgery within the last 3 months
- History of gastrointestinal or urinary tract bleeding within the last 21 days
- History of major surgery or significant trauma other than head injury within the last 14 days
- Hypersensitivity to alteplase
- Suspected subarachnoid hemorrhage
- Concurrent acute aortic dissection
- Concurrent hemorrhage (e.g., intracranial, gastrointestinal, urinary tract, or retroperitoneal, hemoptysis)
- Systolic blood pressure ≥185 mmHg despite antihypertensive therapy
- Diastolic blood pressure ≥110 mmhg despite antihypertensive therapy
- Significant hepatic disorder
- Acute pancreatitis
- Blood glucose <50mg/dL or >400 mg/dL
- Platelet count ≤100,000/mm3
- International normalized ratio of prothrombin time (PT-INR) >1.7 or Prolonged activated partial thromboplastin time (aPTT: >1.5 times the baseline value [>approximately 40 seconds only as a guide]) for patients on anticoagulation therapy or those with abnormal coagulation
- Any contraindication to MRI (e.g. cardiac pacemaker)
- Extensive early ischemic change in brain stem or cerebellum (e.g., more than half of brain stem or more than one hemisphere of cerebellum)
- Planned or anticipated treatment with surgery or endovascular reperfusion strategies (e.g., intra-arterial thrombolysis, mechanical recanalization techniques)
- Pregnant, lactating, or potentially pregnant
- Life expectancy 6 months or less by judgment of the investigator
- Inappropriate for study enrollment by judgment of the investigator

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002325
Contact: Masatoshi Koga, MD | +81-6-6833-5012 ext 8701 | koga@ncvc.go.jp |
Japan | |
National Cerebral and Cardiovascular Center | Recruiting |
Suita, Osaka, Japan, 565-8565 | |
Contact: Masatoshi Koga, MD +81-6-6833-5012 ext 8701 koga@ncvc.go.jp | |
Principal Investigator: Kazunori Toyoda, MD |
Principal Investigator: | Kazunori Toyoda, MD | National Cerebral and Cardiovascular Center |
Additional Information:
Publications:
Responsible Party: | Kazunori Toyoda, Director and Chair, Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center |
ClinicalTrials.gov Identifier: | NCT02002325 History of Changes |
Other Study ID Numbers: |
NCVC-STROKE-001 UMIN000011630 ( Registry Identifier: UMIN ) |
First Posted: | December 5, 2013 Key Record Dates |
Last Update Posted: | April 2, 2018 |
Last Verified: | March 2018 |
Additional relevant MeSH terms:
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Plasminogen Tissue Plasminogen Activator Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |