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Trial record 1 of 1 for:    Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
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Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT)

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ClinicalTrials.gov Identifier: NCT00790335
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
McMaster University
Ontario Clinical Oncology Group (OCOG)
National Heart, Lung, and Blood Institute (NHLBI)
BSN Medical Inc
Genentech, Inc.
Medtronic - MITG
Boston Scientific Corporation
Mid America Heart Institute
Society of Interventional Radiology Foundation
Massachusetts General Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Deep Vein Thrombosis
Venous Thrombosis
Postphlebitic Syndrome
Venous Thromboembolism
Post Thrombotic Syndrome
Intervention: Drug: Recombinant tissue plasminogen activator (rt-PA)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
A-Intervention

Pharmacomechanical catheter-directed thrombolysis (PCDT) with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

B-Control Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target international normalized ratio [INR} 2.0 - 3.0). Elastic compression stockings will be prescribed

Participant Flow:   Overall Study
    A-Intervention   B-Control
STARTED   337   355 
COMPLETED   257   243 
NOT COMPLETED   80   112 



  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.
One patient was found not to meet the study inclusion criterion, and was excluded from all analyses by the adjudication committee.

Reporting Groups
  Description
A-Intervention

PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm

Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

B-Control Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed
Total Total of all reporting groups

Baseline Measures
   A-Intervention   B-Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 336   355   691 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 52 
 (41 to 62) 
 53 
 (43 to 62) 
 53 
 (42 to 62) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      131  39.0%      134  37.7%      265  38.4% 
Male      205  61.0%      221  62.3%      426  61.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      15   4.5%      26   7.3%      41   5.9% 
Not Hispanic or Latino      310  92.3%      319  89.9%      629  91.0% 
Unknown or Not Reported      11   3.3%      10   2.8%      21   3.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.3%      3   0.8%      4   0.6% 
Asian      1   0.3%      4   1.1%      5   0.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      61  18.2%      62  17.5%      123  17.8% 
White      265  78.9%      276  77.7%      541  78.3% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      8   2.4%      10   2.8%      18   2.6% 
Body-mass index 
[Units: Kilograms per square meter]
Median (Inter-Quartile Range)
 31 
 (27 to 36) 
 30 
 (26 to 35) 
 31 
 (27 to 35) 
Symptom severity score [1] 
[Units: Participants]
Count of Participants
     
None or very mild (0-4)      57  17.0%      69  19.4%      126  18.2% 
Mild (5-9)      115  34.2%      124  34.9%      239  34.6% 
Moderate (10-14)      98  29.2%      94  26.5%      192  27.8% 
Severe (> 14)      66  19.6%      66  18.6%      132  19.1% 
Not documented      0   0.0%      2   0.6%      2   0.3% 
[1] The Villalta scale was used to define baseline symptom severity
Side of index DVT 
[Units: Participants]
Count of Participants
     
Left leg      207  61.6%      218  61.4%      425  61.5% 
Right leg      129  38.4%      137  38.6%      266  38.5% 
Previous DVT or PE [1] 
[Units: Participants]
Count of Participants
 83   87   170 
[1] DVT = deep vein thrombosis; PE = pulmonary embolism
Previous ipsilateral DVT [1] 
[Units: Participants]
Count of Participants
 5   14   19 
[1] DVT = deep vein thrombosis
DVT extends into iliac or common femoral vein [1] 
[Units: Participants]
Count of Participants
 195   196   391 
[1] Patients with DVT extending into the iliac or common femoral vein are termed "iliofemoral DVT" and those whose DVT did not extend that high are termed "femoropopliteal DVT".
DVT risk factors 
[Units: Participants]
Count of Participants
     
Major surgery      27   8.0%      34   9.6%      61   8.8% 
Hospitalization      26   7.7%      38  10.7%      64   9.3% 
Plaster cast immobilization      8   2.4%      9   2.5%      17   2.5% 
Childbirth      3   0.9%      5   1.4%      8   1.2% 
None of the above risk factors      272  81.0%      269  75.8%      541  78.3% 
Outpatient 
[Units: Participants]
Count of Participants
 268   300   568 
Time from symptom start to randomization 
[Units: Days]
Median (Inter-Quartile Range)
 6 
 (4 to 10) 
 6 
 (4 to 9) 
 6 
 (4 to 10) 
Aspirin use within past 7 days 
[Units: Participants]
Count of Participants
 68   74   142 
Estimated glomerular filtration rate 
[Units: Milliliters per minute]
Median (Inter-Quartile Range)
 86 
 (70 to 102) 
 86 
 (71 to 102) 
 86 
 (71 to 102) 
Hypertension 
[Units: Participants]
Count of Participants
 143   139   282 
Diabetes 
[Units: Participants]
Count of Participants
 59   54   113 
High cholesterol 
[Units: Participants]
Count of Participants
 97   105   202 
Asthma 
[Units: Participants]
Count of Participants
 36   38   74 
Chronic obstructive pulmonary disease [1] 
[Units: Participants]
Count of Participants
 9   15   24 
[1] COPD = chronic obstructive pulmonary disease
Angina or myocardial infarction [1] 
[Units: Participants]
Count of Participants
 13   15   28 
[1] MI = myocardial infarction
Congestive heart failure 
[Units: Participants]
Count of Participants
 13   19   32 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 174  (11)   174  (10)   174  (11) 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 97  (25)   96  (24)   97  (24) 


  Outcome Measures

1.  Primary:   Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)   [ Time Frame: Between 6 and 24 months after randomization ]

2.  Secondary:   Major Non-post-thrombotic Syndrome Treatment Failure   [ Time Frame: Through 24 months ]

3.  Secondary:   Any Treatment Failure   [ Time Frame: Through 24 months ]

4.  Secondary:   Moderate-to-severe Post-thrombotic Syndrome   [ Time Frame: Between 6 and 24 months after randomization ]

5.  Secondary:   Major Bleeding   [ Time Frame: Within 10 days after randomization ]

6.  Secondary:   Major Bleeding   [ Time Frame: Within 24 months after randomization ]

7.  Secondary:   Any (Minor + Major) Bleeding   [ Time Frame: Within 10 days after randomization ]

8.  Secondary:   Any (Major + Minor) Bleeding   [ Time Frame: Within 24 months after randomization ]

9.  Secondary:   Recurrent Venous Thromboembolism   [ Time Frame: Within 10 days after randomization ]

10.  Secondary:   Recurrent Venous Thromboembolism   [ Time Frame: Within 24 months after randomization ]

11.  Secondary:   Death   [ Time Frame: Within 10 days after randomization ]

12.  Secondary:   Death   [ Time Frame: Within 24 months after randomization ]

13.  Secondary:   Severity of Post-thrombotic Syndrome (Villalta)   [ Time Frame: At 6 months ]

14.  Secondary:   Severity of Post-thrombotic Syndrome (Villalta)   [ Time Frame: At 12 months ]

15.  Secondary:   Severity of Post-thrombotic Syndrome (Villalta)   [ Time Frame: At 18 months ]

16.  Secondary:   Severity of Post-thrombotic Syndrome (Villalta)   [ Time Frame: At 24 months ]

17.  Secondary:   Venous Clinical Severity Score   [ Time Frame: At 6 months ]

18.  Secondary:   Venous Clinical Severity Score   [ Time Frame: At 12 months ]

19.  Secondary:   Venous Clinical Severity Score   [ Time Frame: At 18 months ]

20.  Secondary:   Venous Clinical Severity Score   [ Time Frame: At 24 months ]

21.  Secondary:   Change in General Quality of Life - Physical   [ Time Frame: Baseline to 24 months post-randomization ]

22.  Secondary:   Change in General Quality of Life - Mental   [ Time Frame: Baseline to 24 months post-randomization ]

23.  Secondary:   Change in Venous Disease-specific Quality of Life   [ Time Frame: Baseline to 24 months post-randomization ]

24.  Secondary:   Change in Leg Pain Severity   [ Time Frame: Baseline to 10 days post-randomization ]

25.  Secondary:   Change in Leg Pain Severity   [ Time Frame: Baseline to 30 days post-randomization ]

26.  Secondary:   Change in Leg Circumference   [ Time Frame: Baseline to 10 days post-randomization ]

27.  Secondary:   Change in Leg Circumference   [ Time Frame: Baseline to 30 days post-randomization ]


  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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Suresh Vedantham, Principal Investigator
Organization: Washington University in St. Louis
phone: 3143622900 ext 314
e-mail: vedanthams@mir.wustl.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00790335     History of Changes
Other Study ID Numbers: 22326953211
U01HL088476-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 15, 2008
First Posted: November 13, 2008
Results First Submitted: December 18, 2017
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018