Trial · NCT02394730
Attenuation of D-dimer Using Vorapaxar to Target Inflammatory and Coagulation Endpoints
NCT02394730, Phase 1, Phase 2, Completed, Kirby Institute; results first posted 2019-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Attenuation of D-dimer Using Vorapaxar to Target Inflammatory and Coagulation Endpoints. Trials, record NCT02394730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02394730
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Attenuation of D-dimer Using Vorapaxar to Target Inflammatory and Coagulation Endpoints
- NCT number
- NCT02394730
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Kirby Institute
- Conditions
- HIV
- Interventions
- vorapaxar, Placebo
- First posted
- 2015-03-20
- Last updated
- 2019-03-06
- Results first posted
- 2019-02-28
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percent Change From Baseline for D-dimer (ng/mL) to the Average of Weeks 8 and 12 | at week 8 and week 12 | Mean of week 8 and week 12 minus week 0 (on log10 scale) then back transforming the log10 difference to obtain percentage change from baseline. |
| Secondary | Number of Participants in Each Treatment Group With Plasma HIV-1 RNA <50 Copies/mL | at week 18 | Number of participants in each treatment group with plasma HIV-1 RNA \<50 copies/mL at week 18 |
| Secondary | Mean Change From Baseline to Week 12 in CD4+ Cell Counts | at week 12 | Mean of week 12 CD4+ cell count minus mean of week 0 CD4+ cell count |
| Secondary | Mean Change From Baseline to Week 12 in CD8+ Cell Counts | at week 12 | Mean of week 12 CD8+ cell count minus mean of week 0 CD4+ cell count |
| Secondary | Number of Patients in Each Treatment Group With D-dimer <165ng/mL at Week 12 | week 12 | Number of patients in each treatment group with d-dimer \<165ng/mL at week 12 |
| Secondary | Number of Patients in Each Treatment Group With D-dimer > or Equal to 165ng/mL at Week 18 | week 18 | Number of patients in each treatment group with d-dimer \> or equal to 165ng/mL at week 18 |
| Secondary | Mean Change From Baseline in log10 D-Dimer | at week 18 | Differences between treatment groups in mean change from week 0 log10 d-dimer to week 18 |
| Secondary | Mean Change From Baseline in log10 Hs-CRP at Week 18 | at week 18 | Differences between treatment groups in mean change from baseline log10 hs-CRP to week 18. ie Week 18 log10 hs-CRP minus week 0 log10 hs-CRP |
| Secondary | Percent Change From Baseline Hs-CRP (ug/mL) to the Average of Week 8 and Week 12 | week 8 and 12 | Mean of week 8 and week 12 minus week 0 (on log10 scale) then back transformed the log10 difference to obtain percentage change from baseline. |
| Secondary | Mean Percent Change From Baseline IL-6 (pg/mL) to the Average of Week 8 and Week 12 | at week 8 and week 12 | Mean of week 8 and week 12 minus week 0 (on log10 scale) then back transformed the log10 difference to obtain percentage change from baseline. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percent Change From Baseline for D-dimer (ng/mL) to the Average of Weeks 8 and 12 | at week 8 and week 12 | percent | MEAN | |
| SECONDARY | Number of Participants in Each Treatment Group With Plasma HIV-1 RNA <50 Copies/mL | at week 18 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change From Baseline to Week 12 in CD4+ Cell Counts | at week 12 | cells/mm3 | MEAN | |
| SECONDARY | Mean Change From Baseline to Week 12 in CD8+ Cell Counts | at week 12 | cells/mm3 | MEAN | |
| SECONDARY | Number of Patients in Each Treatment Group With D-dimer <165ng/mL at Week 12 | week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients in Each Treatment Group With D-dimer > or Equal to 165ng/mL at Week 18 | week 18 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change From Baseline in log10 D-Dimer | at week 18 | percent change | MEAN | |
| SECONDARY | Mean Change From Baseline in log10 Hs-CRP at Week 18 | at week 18 | pg/mL | MEAN | |
| SECONDARY | Percent Change From Baseline Hs-CRP (ug/mL) to the Average of Week 8 and Week 12 | week 8 and 12 | Percent | MEAN | |
| SECONDARY | Mean Percent Change From Baseline IL-6 (pg/mL) to the Average of Week 8 and Week 12 | at week 8 and week 12 | percent | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percent Change From Baseline for D-dimer (ng/mL) to the Average of Weeks 8 and 12 | Vorapaxar | -10.8 | 95% Confidence Interval -23.1 to 3.4 | percent | |
| Mean Percent Change From Baseline for D-dimer (ng/mL) to the Average of Weeks 8 and 12 | Placebo | -8.5 | 95% Confidence Interval -18.4 to 2.5 | percent | |
| Number of Participants in Each Treatment Group With Plasma HIV-1 RNA <50 Copies/mL | Vorapaxar | 31 | Participants | ||
| Number of Participants in Each Treatment Group With Plasma HIV-1 RNA <50 Copies/mL | Placebo | 29 | Participants | ||
| Mean Change From Baseline to Week 12 in CD4+ Cell Counts | Vorapaxar | -21.3 | Standard Deviation 143.7 | cells/mm3 | |
| Mean Change From Baseline to Week 12 in CD4+ Cell Counts | Placebo | -29.7 | Standard Deviation 400.3 | cells/mm3 | |
| Mean Change From Baseline to Week 12 in CD8+ Cell Counts | Vorapaxar | 3 | Standard Deviation 191.6 | cells/mm3 | |
| Mean Change From Baseline to Week 12 in CD8+ Cell Counts | Placebo | 81.1 | Standard Deviation 244.7 | cells/mm3 | |
| Number of Patients in Each Treatment Group With D-dimer <165ng/mL at Week 12 | Vorapaxar | 1 | Participants | ||
| Number of Patients in Each Treatment Group With D-dimer <165ng/mL at Week 12 | Placebo | 2 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vorapaxar | 34 | |
| Overall Study | STARTED | Placebo | 31 | |
| Overall Study | COMPLETED | Vorapaxar | 33 | |
| Overall Study | COMPLETED | Placebo | 30 | |
| Overall Study | NOT COMPLETED | Vorapaxar | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events38
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 | Upper Respiratory Tract Injection | Respiratory, thoracic and mediastinal disorders | Vorapaxar | 4 | 33 | 4 |
| other | Upper Respiratory Tract Injection | Respiratory, thoracic and mediastinal disorders | Placebo | 7 | 31 | 8 |
| other | Laceration | Injury, poisoning and procedural complications | Vorapaxar | 3 | 33 | 3 |
| other | Laceration | Injury, poisoning and procedural complications | Placebo | 3 | 31 | 3 |
| other | Epistaxis | Blood and lymphatic system disorders | Vorapaxar | 4 | 33 | 6 |
| other | Epistaxis | Blood and lymphatic system disorders | Placebo | 2 | 31 | 2 |
| other | Headache | Nervous system disorders | Vorapaxar | 4 | 33 | 4 |
| other | Headache | Nervous system disorders | Placebo | 2 | 31 | 2 |
| other | Contusion | Musculoskeletal and connective tissue disorders | Vorapaxar | 1 | 33 | 1 |
| other | Contusion | Musculoskeletal and connective tissue disorders | Placebo | 3 | 31 | 3 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vorapaxar | 0 | 33 |
| Total, all-cause mortality | Placebo | 0 | 31 |
| Total, other adverse events | Vorapaxar | 15 | 33 |
| Total, other adverse events | Placebo | 22 | 31 |
| Total, serious adverse events | Vorapaxar | 2 | 33 |
| Total, serious adverse events | Placebo | 2 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30257802 | DERIVED |
Source PubMed
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vorapaxar vs Placebo: Total Number of Participants With Any AE Between Baseline to Week 18 | Trial comparisons |
| Vorapaxar vs Placebo: Number of Patients in Each Treatment Group With D-dimer <165ng/mL at Week 12 | Trial comparisons |
| Vorapaxar vs Placebo: Number of Patients in Each Treatment Group With D-dimer > or Equal to 165ng/mL at Week 18 | Trial comparisons |
| Vorapaxar vs Placebo: Total Number of Participants With Any SAE Between Baseline and Week 18 | Trial comparisons |
| Vorapaxar vs Placebo: Total Number of Participants With BARC Type 1, 2, 3, 4, or 5 Bleeding Episodes | Trial comparisons |
| Vorapaxar vs Placebo: Number of Participants in Each Treatment Group With Plasma HIV-1 RNA <50 Copies/mL | Trial comparisons |
| Vorapaxar vs Placebo: deaths from any cause | Trial comparisons |
| Vorapaxar vs Placebo: serious adverse events | Trial comparisons |
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/NCT02394730
GET https://conductscience.org/api/trials/v1/NCT02394730/results?page=2