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

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. Read our disclaimer for details.
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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
MRI- Selected Patients

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.

Non-MRI Selected Patients

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.


Participant Flow:   Overall Study
    MRI- Selected Patients   Non-MRI Selected Patients
STARTED   15   3 
Aspirin and Tinzaparin   15   3 
COMPLETED   15   3 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MRI- Selected Patients

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.

Non-MRI Selected Patients

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 Total of all reporting groups

Baseline Measures
   MRI- Selected Patients   Non-MRI Selected Patients   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   3   18 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   5   2   7 
>=65 years   10   1   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 70  (9)   59  (7)   68  (9) 
Gender 
[Units: Participants]
     
Female   8   1   9 
Male   7   2   9 
Region of Enrollment 
[Units: Participants]
     
United States   15   3   18 


  Outcome Measures

1.  Primary:   Symptomatic Intracerebral Hemorrhage (ICH)   [ Time Frame: From the start of study drugs and prior to the 72-hour safety head CT ]

2.  Primary:   Major Systemic Hemorrhage   [ Time Frame: From the start of study drugs and prior to 72-hour head CT ]

3.  Primary:   Other Serious Adverse Event Related to Study Drug Administration, Including Death.   [ Time Frame: From start of study drugs and prior to 72-hour head CT ]

4.  Primary:   MRI Selected Arm: Complete Brain Reperfusion   [ Time Frame: up to 24 hours from the start of study drugs ]

5.  Primary:   Non-MRI Selected Arm: Substantial Clinical Recovery (Non-MRI Arm)   [ Time Frame: up to 24 hours from the start of study drugs ]

6.  Secondary:   Bleeding Events   [ Time Frame: 2 hr, 24 hr, 72 hr, 5 days, 30 days from start of study drugs ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: swarach@seton.org


Publications:

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