Trial Outcomes & Findings for Argatroban Stroke Treatment - A Pilot Safety Study (NCT NCT00268762)
NCT ID: NCT00268762
Last Updated: 2014-11-10
Results Overview
Significant intracerebral hemorrhage as defined by either: 1. Symptomatic intracerebral hemorrhage or 2. Parenchymal hematoma type 2.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Within 7 days of enrollment
Results posted on
2014-11-10
Participant Flow
Date of first enrollment: May 6, 2003 Date of last enrollment: August 20, 2010 All patients enrolled through hospital emergency departments
Participant milestones
| Measure |
Intervention
Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target partial thromboplastin time (PTT) of 1.75 times the patient's baseline.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Argatroban Stroke Treatment - A Pilot Safety Study
Baseline characteristics by cohort
| Measure |
Intervention
n=65 Participants
Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days of enrollmentSignificant intracerebral hemorrhage as defined by either: 1. Symptomatic intracerebral hemorrhage or 2. Parenchymal hematoma type 2.
Outcome measures
| Measure |
Intervention
n=65 Participants
Argatroban IV Infusion 1 mcg/kg/min for 48 hours
|
|---|---|
|
Symptomatic and Radiographic Intracerebral Hemorrhage
|
6.2 percentage of patients
Interval 1.7 to 15.0
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SECONDARY outcome
Timeframe: 2 hours complete recanalization post tPA bolusComplete Recanalization as measured by either transcranial Doppler Ultrasound at 2 hours post tPA bolus.
Outcome measures
| Measure |
Intervention
n=47 Participants
Argatroban IV Infusion 1 mcg/kg/min for 48 hours
|
|---|---|
|
Arterial Complete Recanalization at 2 Hours Post tPA Bolus
|
40 percent of patients
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SECONDARY outcome
Timeframe: 24 hours from tPA bolusComplete recanalization at 24 hours post tPA bolus as measured by either transcranial Doppler ultrasound or CT-Angiography.
Outcome measures
| Measure |
Intervention
n=60 Participants
Argatroban IV Infusion 1 mcg/kg/min for 48 hours
|
|---|---|
|
Arterial Complete Recanalization at 24 Hours Post tPA Bolus
|
63 percent of patients
|
Adverse Events
Intervention
Serious events: 21 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=65 participants at risk
Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
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|---|---|
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General disorders
Death
|
10.8%
7/65 • Number of events 7 • 90 days during the study period
|
|
Nervous system disorders
Stroke progression or neurological worsening
|
7.7%
5/65 • Number of events 5 • 90 days during the study period
|
|
Nervous system disorders
Significant intracerebral hemorrhage
|
6.2%
4/65 • Number of events 4 • 90 days during the study period
|
|
Nervous system disorders
Cerebral edema
|
6.2%
4/65 • Number of events 4 • 90 days during the study period
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia/respiratory failure
|
4.6%
3/65 • Number of events 3 • 90 days during the study period
|
|
Cardiac disorders
Cardiac arrest
|
4.6%
3/65 • Number of events 3 • 90 days during the study period
|
|
Nervous system disorders
Asymptomatic ICH
|
3.1%
2/65 • Number of events 2 • 90 days during the study period
|
|
Blood and lymphatic system disorders
Significant laboratory abnormality
|
3.1%
2/65 • Number of events 2 • 90 days during the study period
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Nervous system disorders
Seizure
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
Other adverse events
| Measure |
Intervention
n=65 participants at risk
Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
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|---|---|
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Gastrointestinal disorders
Nausea with or without Emesis
|
4.6%
3/65 • Number of events 3 • 90 days during the study period
|
|
Cardiac disorders
Chest Pain
|
3.1%
2/65 • Number of events 2 • 90 days during the study period
|
|
Cardiac disorders
Hypotension
|
4.6%
3/65 • Number of events 3 • 90 days during the study period
|
|
Cardiac disorders
Tachycardia
|
10.8%
7/65 • Number of events 7 • 90 days during the study period
|
|
Cardiac disorders
Patent Foramen Ovale
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Cardiac disorders
Aortic valve vegetation
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Cardiac disorders
Atrial Fibrillation
|
3.1%
2/65 • Number of events 2 • 90 days during the study period
|
|
Cardiac disorders
Hypothermia
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Cardiac disorders
Hypertension
|
4.6%
3/65 • Number of events 3 • 90 days during the study period
|
|
General disorders
Laboratory abnormalities - Chemistries
|
15.4%
10/65 • Number of events 14 • 90 days during the study period
|
|
Endocrine disorders
New diagnosis of diabetes mellitus
|
3.1%
2/65 • Number of events 2 • 90 days during the study period
|
|
Renal and urinary disorders
Oliguria
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Renal and urinary disorders
Urinary Retention
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Renal and urinary disorders
Urinary Analysis laboratory abnormality
|
4.6%
3/65 • Number of events 3 • 90 days during the study period
|
|
Blood and lymphatic system disorders
Anemia/decrease in hemoglobin and hematocrit level
|
6.2%
4/65 • Number of events 5 • 90 days during the study period
|
|
Nervous system disorders
Asymptomatic Intracranial Hemorhhage
|
20.0%
13/65 • Number of events 13 • 90 days during the study period
|
|
Infections and infestations
Fever
|
26.2%
17/65 • Number of events 17 • 90 days during the study period
|
|
Infections and infestations
Urinary Tract Infection
|
29.2%
19/65 • Number of events 19 • 90 days during the study period
|
|
Infections and infestations
Pneumonia
|
4.6%
3/65 • Number of events 3 • 90 days during the study period
|
|
Musculoskeletal and connective tissue disorders
Minimally displaced fracture of base of fifth metacarpal
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Musculoskeletal and connective tissue disorders
Hand swelling
|
3.1%
2/65 • Number of events 2 • 90 days during the study period
|
|
Nervous system disorders
Agitation/lethargic/somnolent
|
3.1%
2/65 • Number of events 2 • 90 days during the study period
|
|
Nervous system disorders
Stroke progression
|
3.1%
2/65 • Number of events 2 • 90 days during the study period
|
|
Nervous system disorders
Neuro-worsening
|
4.6%
3/65 • Number of events 3 • 90 days during the study period
|
|
General disorders
Exacerbation of uterine prolapse
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
General disorders
Oral thrush
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Psychiatric disorders
Excessive sleepness
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
General disorders
Self extubation
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Psychiatric disorders
Visual hallucination
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Psychiatric disorders
Restless
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Respiratory, thoracic and mediastinal disorders
Right lung mass
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Respiratory, thoracic and mediastinal disorders
Coughing/gagging
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Respiratory, thoracic and mediastinal disorders
Both lung with rales
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
10.8%
7/65 • Number of events 7 • 90 days during the study period
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
2/65 • Number of events 2 • 90 days during the study period
|
|
Skin and subcutaneous tissue disorders
Slight angioedema
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
|
General disorders
Laboratory Abnormalities - Electrolytes
|
20.0%
13/65 • Number of events 19 • 90 days during the study period
|
|
General disorders
Laboratory Abnormalities - Elevated PTT >100 seconds
|
1.5%
1/65 • Number of events 1 • 90 days during the study period
|
Additional Information
Andrew D. Barreto, MD
University of Texas Health Science Center at Houston
Phone: 713-500-7002
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place