Trial · NCT00082355
Low-Dose Alteplase to Treat Blood Clots in Deep Leg Veins
NCT00082355, Phase 2, Completed, Richard Chang, M.D.; results first posted 2012-12-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Low-Dose Alteplase to Treat Blood Clots in Deep Leg Veins. Trials, record NCT00082355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00082355
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low-Dose Alteplase to Treat Blood Clots in Deep Leg Veins
- NCT number
- NCT00082355
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Richard Chang, M.D.
- Conditions
- Acute Deep Venous Thrombosis of the Lower Extremity
- Interventions
- Alteplase (Activase, Genentech)
- First posted
- 2004-05-06
- Last updated
- 2014-11-06
- Results first posted
- 2012-12-19
- Limitations and caveats
- Small trial of 30 patients does not have statistical power to prove clinical safety (expected to be \<1 %)
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Restored Venous Function | 6 months | The outcome measures the ability of Alteplase to lyse acute and subacute deep venous thrombosis (DVT) of the lower extremities and/or pelvis and restore venous function, or blood flow, to these areas. Restored venous function is also known as patency. Patency is measured by venography and ultrasound exams. |
| Secondary | Number of Participants That Developed Hemorrhage | 5 days | The outcome measures the number of participants who developed hemorrhage after receiving up to 4 days of Alteplase treatment for DVT. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Restored Venous Function | 6 months | The number of participants analyzed is an Intent-to-Treat (ITT) population. The initial goal was to be able to evaluate outcomes of treatment of DVT with alteplase over a 6 month period in 25 patients. 30 patients were treated but two participants did not complete the study before being assessed for this outcome measure. | participants | NUMBER |
| SECONDARY | Number of Participants That Developed Hemorrhage | 5 days | The number of participants analyzed is an Intent-to-Treat (ITT) population. The accrual target was to analyze outcomes(immediate, at 6 weeks, and at 6months) after treatment of DVT with alteplase in 25 patients. 30 patients were treated but two participants did not complete the study for 6 week and 6 month outcome assessments. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Restored Venous Function | Alteplase | 28 | participants | ||
| Number of Participants That Developed Hemorrhage | Alteplase | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Results of Thrombolytic Therapy | STARTED | Alteplase | 30 | |
| Initial Results of Thrombolytic Therapy | COMPLETED | Alteplase | 28 | |
| Initial Results of Thrombolytic Therapy | NOT COMPLETED | Alteplase | 2 | |
| 5 Year Recurrent Thromboembolism Rate | STARTED | Alteplase | 28 | |
| 5 Year Recurrent Thromboembolism Rate | COMPLETED | Alteplase | 0 | |
| 5 Year Recurrent Thromboembolism Rate | NOT COMPLETED | Alteplase | 28 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | catheter insertion site hematoma | Vascular disorders | Alteplase | 2 | 30 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alteplase | ||
| Total, other adverse events | Alteplase | 2 | 30 |
| Total, serious adverse events | Alteplase | 0 | 30 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00082355
GET https://conductscience.org/api/trials/v1/NCT00082355/registered