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Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial (CATALIST) (CATALIST)

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ClinicalTrials.gov Identifier: NCT00061373
Recruitment Status : Completed
First Posted : May 26, 2003
Results First Posted : February 4, 2013
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ischemic Stroke
Interventions Drug: Aspirin
Drug: tinzaparin sodium
Drug: eptifibatide
Enrollment 18
Recruitment Details Recruitment for this clinical trial opened in 2004 and closed in 2009. Patients who presented to one of two metropolitan Washington, DC hospitals with acute ischemic stroke and who treated with standard iv tPA were screened for study enrollment.
Pre-assignment Details Enrollment into the MRI was preferential. If patients had contraindications to MRI or acquisition of MRI delayed treatment with iv tPA, they were enrolled in the non-MRI arm of the study.
Arm/Group Title MRI- Selected Patients Non-MRI Selected Patients
Hide Arm/Group Description

Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Period Title: Overall Study
Started 15 3
Aspirin and Tinzaparin 15 3
Completed 15 3
Not Completed 0 0
Arm/Group Title MRI- Selected Patients Non-MRI Selected Patients Total
Hide Arm/Group Description

Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Total of all reporting groups
Overall Number of Baseline Participants 15 3 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 3 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  33.3%
2
  66.7%
7
  38.9%
>=65 years
10
  66.7%
1
  33.3%
11
  61.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 3 participants 18 participants
70  (9) 59  (7) 68  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 3 participants 18 participants
Female
8
  53.3%
1
  33.3%
9
  50.0%
Male
7
  46.7%
2
  66.7%
9
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 3 participants 18 participants
15 3 18
1.Primary Outcome
Title Symptomatic Intracerebral Hemorrhage (ICH)
Hide Description

This is a primary safety outcome or toxicity measure for all subjects.

Symptomatic ICH is defined as the presence of two conditions: evidence of hemorrhage on the 72-hour head CT and an increase in the NIHSS score of 4 or more points from the prior examination. Hemorrhage classifications are according to European Cooperative Acute Stroke Study (ECASS).

The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have "normal" examination. Patients with a score of 40 have the most severe stroke symptoms.

Time Frame From the start of study drugs and prior to the 72-hour safety head CT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients had a 72-hour safety head CT performed
Arm/Group Title MRI- Selected Patients Non-MRI Selected Patients
Hide Arm/Group Description:

Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Overall Number of Participants Analyzed 15 3
Measure Type: Number
Unit of Measure: participants
1 1
2.Primary Outcome
Title Major Systemic Hemorrhage
Hide Description Major systemic hemorrhage is defined bleeding associated with an adjusted decrease in hemoglobin of greater than 5 grams per diluent (g/dL), or and adjusted decrease in hematocrit greater than or equal to 15 percentage points or bleeding causing persistent or significant disability or incapacity such as hemorrhage in the eye.
Time Frame From the start of study drugs and prior to 72-hour head CT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients completed 72-hour safety evaluation
Arm/Group Title MRI- Selected Patients Non-MRI Selected Patients
Hide Arm/Group Description:

Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Overall Number of Participants Analyzed 15 3
Measure Type: Number
Unit of Measure: participants
0 0
3.Primary Outcome
Title Other Serious Adverse Event Related to Study Drug Administration, Including Death.
Hide Description This is a primary safety outcome for all subjects.
Time Frame From start of study drugs and prior to 72-hour head CT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Patients completed 72-hour study safety evaluation
Arm/Group Title MRI- Selected Patients Non-MRI Selected Patients
Hide Arm/Group Description:

Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Overall Number of Participants Analyzed 15 3
Measure Type: Number
Unit of Measure: participants
0 0
4.Primary Outcome
Title MRI Selected Arm: Complete Brain Reperfusion
Hide Description This is the primary response outcome measure for patients in the MRI arm. A positive response is measured by evidence of complete reperfusion (or restoration of blood flow)on the perfusion weighted images (PWI) and mean transit time (MTT) maps of MRIs at 2 hours and sustained at 24 hours.
Time Frame up to 24 hours from the start of study drugs
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Complete reperfusion at 2 and 24 hours was measured in MRI-selected patients only.
Arm/Group Title MRI- Selected Patients Non-MRI Selected Patients
Hide Arm/Group Description:

Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Overall Number of Participants Analyzed 14 0
Measure Type: Number
Unit of Measure: participants
0
5.Primary Outcome
Title Non-MRI Selected Arm: Substantial Clinical Recovery (Non-MRI Arm)
Hide Description

This is the primary response outcome measure for subjects in the non-MRI arm. A positive response is measured by a 7 point or more improvement in the NIHSS or for those with less than 7 points at baseline,complete resolution of stroke symptoms.

The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have "normal" examination. Patients with a score of 40 have the most severe stroke symptoms.

Time Frame up to 24 hours from the start of study drugs
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Clinical improvement on NIHSS of 7 points or greater at 72 hours is the primary response outcome for non-MRI selected patients. Clinical response outcome was analyzed on all patients enrolled; MRI selected and non-selected patients.
Arm/Group Title MRI- Selected Patients Non-MRI Selected Patients
Hide Arm/Group Description:

Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Overall Number of Participants Analyzed 15 3
Measure Type: Number
Unit of Measure: participants
3 2
6.Secondary Outcome
Title Bleeding Events
Hide Description Bleeding events of any type, severity and at any time throughout the 30-day trial period.
Time Frame 2 hr, 24 hr, 72 hr, 5 days, 30 days from start of study drugs
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All bleeding events that occurred among all patients enrolled and throughout the 30-day trial period but not classified as a primary outcome event. Bleeding events in this category include asymptomatic ICH(aICH);major systemic bleeding after 72 hours or minor and non-significant bleeding at anytime within the 30-day period.
Arm/Group Title MRI- Selected Patients Non-MRI Selected Patients
Hide Arm/Group Description:

Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Overall Number of Participants Analyzed 15 3
Measure Type: Number
Unit of Measure: participants
8 1
Time Frame Adverse events were monitored from the start of study drug administration through the 30-day study period.
Adverse Event Reporting Description All cases of ICH were reported to and reviewed by the DSMB. Patients with symptomatic ICH prior to the 72-hour head CT were reviewed by the DSMB prior to enrollment of new patients.
 
Arm/Group Title MRI- Selected Patients Non-MRI Selected Patients
Hide Arm/Group Description

Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.

Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA.

All-Cause Mortality
MRI- Selected Patients Non-MRI Selected Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MRI- Selected Patients Non-MRI Selected Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/15 (26.67%)      2/3 (66.67%)    
Blood and lymphatic system disorders     
Systemic Bleeding/Anemia   1/15 (6.67%)  1 0/3 (0.00%)  0
Cardiac disorders     
Non-ST Segment Elevation Myocardial Infarction (NSTEMI)   1/15 (6.67%)  1 0/3 (0.00%)  0
Endocrine disorders     
Metabolic Disturbance   1/15 (6.67%)  1 0/3 (0.00%)  0
Nervous system disorders     
Neurological Worsening  [1]  1/15 (6.67%)  1 0/3 (0.00%)  0
Symptomatic ICH  [2]  1/15 (6.67%)  1 1/3 (33.33%)  1
Renal and urinary disorders     
Urinary Tract Infection   1/15 (6.67%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism   1/15 (6.67%)  1 0/3 (0.00%)  0
Vascular disorders     
Deep Vein Thrombosis  [3]  1/15 (6.67%)  1 2/3 (66.67%)  2
Indicates events were collected by systematic assessment
[1]
measured by change in NIHSS score of 4 or more points
[2]
reading of non-contrast head CT for all and reading of gradient echo (GRE) for MRI-selected patients
[3]
doppler confirmed
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MRI- Selected Patients Non-MRI Selected Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/15 (80.00%)      2/3 (66.67%)    
Blood and lymphatic system disorders     
Thrombocytopenia   1/15 (6.67%)  1 0/3 (0.00%)  0
Cardiac disorders     
Sinus bradycardia, asymptomatic   1/15 (6.67%)  1 1/3 (33.33%)  1
Atrial Fibrillation   1/15 (6.67%)  1 1/3 (33.33%)  1
Hypotension   2/15 (13.33%)  3 0/3 (0.00%)  0
Sick Sinus Syndrome   1/15 (6.67%)  1 0/3 (0.00%)  0
Gastrointestinal disorders     
Nausea *  0/15 (0.00%)  0 1/3 (33.33%)  1
Constipation *  1/15 (6.67%)  1 0/3 (0.00%)  0
Vomiting *  2/15 (13.33%)  2 0/3 (0.00%)  0
Hepatobiliary disorders     
Elevated Liver Enzymes   1/15 (6.67%)  1 0/3 (0.00%)  0
Infections and infestations     
Fever   4/15 (26.67%)  5 1/3 (33.33%)  1
Metabolism and nutrition disorders     
Electrolyte imbalance   2/15 (13.33%)  4 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain, lower extremity   1/15 (6.67%)  1 0/3 (0.00%)  0
Nervous system disorders     
Headache   5/15 (33.33%)  5 2/3 (66.67%)  2
Asymptomatic ICH   6/15 (40.00%)  6 1/3 (33.33%)  1
Ischemic Stroke, New   1/15 (6.67%)  1 0/3 (0.00%)  0
Expansion of ischemic stroke   1/15 (6.67%)  1 0/3 (0.00%)  0
Agitation *  1/15 (6.67%)  1 0/3 (0.00%)  0
Mood Alteration *  1/15 (6.67%)  1 0/3 (0.00%)  0
Neurological Worsening   2/15 (13.33%)  2 0/3 (0.00%)  0
Renal and urinary disorders     
Urinary Tract Infection   2/15 (13.33%)  2 1/3 (33.33%)  1
Hematuria   1/15 (6.67%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Metabolic Alkalosis   1/15 (6.67%)  1 0/3 (0.00%)  0
Labored Breathing   1/15 (6.67%)  1 0/3 (0.00%)  0
Pulmonary Congestion   1/15 (6.67%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Cellulitis *  1/15 (6.67%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
All patients enrolled were dosed with aspirin and tinzaparin. None of the patients received iv eptifibatide. The study was closed prior to dosing with eptifibatide due to slow recruitment over the 5-year trial period.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Steven Warach, MD, PhD; Principal Investigator
Organization: NIH/NINDS and University of Texas Southwestern, Clinical Research Institute of Austin
Phone: 512-324-8383
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT00061373     History of Changes
Other Study ID Numbers: 030171
03-N-0171
First Submitted: May 23, 2003
First Posted: May 26, 2003
Results First Submitted: December 27, 2012
Results First Posted: February 4, 2013
Last Update Posted: February 4, 2013