Trial Outcomes & Findings for Clot Dissolving Treatment for Blood Clots in the Lungs (NCT NCT00680628)
NCT ID: NCT00680628
Last Updated: 2022-10-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
83 participants
Primary outcome timeframe
1,2,3,4, and 5 days
Results posted on
2022-10-12
Participant Flow
Patients enrolled from 8 hospitals from August 2008 until October, 2012. Genentech funded the study. Carolinas Medical Center was the prime contractor site and subcontracted 7 other hospitals.
The investigator relocated to a new institution in July 2012, which led to insoluble problems with the subcontracts that forced early study closure.
Participant milestones
| Measure |
Placebo
Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: \<60Kg=30mg; ≥60Kg to \<70Kg=35mg; ≥70Kg to \<80Kg=40mg; ≥80Kg to \<90Kg=45mg; ≥90Kg=50mg
|
Tenecteplase
Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
40
|
|
Overall Study
COMPLETED
|
43
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clot Dissolving Treatment for Blood Clots in the Lungs
Baseline characteristics by cohort
| Measure |
Placebo
n=43 Participants
Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: \<60Kg=30mg; ≥60Kg to \<70Kg=35mg; ≥70Kg to \<80Kg=40mg; ≥80Kg to \<90Kg=45mg; ≥90Kg=50mg
|
Tenecteplase
n=40 Participants
Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 14 • n=99 Participants
|
57 years
STANDARD_DEVIATION 14 • n=107 Participants
|
55 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=99 Participants
|
40 participants
n=107 Participants
|
83 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1,2,3,4, and 5 daysOutcome measures
| Measure |
Placebo
n=43 Participants
Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: \<60Kg=30mg; ≥60Kg to \<70Kg=35mg; ≥70Kg to \<80Kg=40mg; ≥80Kg to \<90Kg=45mg; ≥90Kg=50mg
|
Tenecteplase
n=40 Participants
Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline.
|
|---|---|---|
|
Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Placebo
n=43 Participants
Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: \<60Kg=30mg; ≥60Kg to \<70Kg=35mg; ≥70Kg to \<80Kg=40mg; ≥80Kg to \<90Kg=45mg; ≥90Kg=50mg
|
Tenecteplase
n=40 Participants
Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline.
|
|---|---|---|
|
Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36)
|
8 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Placebo
n=43 Participants
Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: \<60Kg=30mg; ≥60Kg to \<70Kg=35mg; ≥70Kg to \<80Kg=40mg; ≥80Kg to \<90Kg=45mg; ≥90Kg=50mg
|
Tenecteplase
n=40 Participants
Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline.
|
|---|---|---|
|
Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome
|
4 participants
|
1 participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Tenecteplase
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=43 participants at risk
Tenecteplase + Enoxaparin
Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.
Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: \<60Kg=30mg; ≥60Kg to \<70Kg=35mg; ≥70Kg to \<80Kg=40mg; ≥80Kg to \<90Kg=45mg; ≥90Kg=50mg
|
Tenecteplase
n=40 participants at risk
Saline + Enoxaparin
0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline.
|
|---|---|---|
|
Nervous system disorders
intracranial hemorrhage
|
0.00%
0/43
|
2.5%
1/40 • Number of events 1
|
|
Cardiac disorders
Cardiogenic shock
|
2.3%
1/43 • Number of events 1
|
0.00%
0/40
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60