Trial · NCT00674297
Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
NCT00674297, Phase 2, Completed, Hospital for Special Surgery, New York; results first posted 2018-05-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients. Trials, record NCT00674297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00674297
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients
- NCT number
- NCT00674297
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Hospital for Special Surgery, New York
- Conditions
- Antiphospholipid Syndrome
- Interventions
- Fluvastatin
- First posted
- 2008-05-07
- Last updated
- 2018-05-01
- Results first posted
- 2018-05-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | 3 months | Biomarkers: IL6 (pg/mL), IL1β (pg/mL), IL8 (pg/mL), VEGF (pg/mL), TNFα (pg/mL), IFNα (pg/mL), IP10 (pg/mL), sCD40L (pg/mL) |
| Primary | Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | 3 months | Biomarker sTF (pM) |
| Primary | Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | 3 months | Biomarkers sICAM-1 (ng/mL), sVCAM-1 (ng/mL), sE-sel (ng/mL) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | 3 months | pg/mL | MEAN | |
| PRIMARY | Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | 3 months | pM | MEAN | |
| PRIMARY | Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | 3 months | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | PAPS | Biomarker IL6 | 31.2 | Standard Deviation 48.4 | pg/mL |
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | SLE/APS | Biomarker IL6 | 12.2 | Standard Deviation 103.5 | pg/mL |
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | Primary aPL | Biomarker IL6 | 0.4 | Standard Deviation 0.7 | pg/mL |
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | SLE/aPL | Biomarker IL6 | 2.7 | Standard Deviation 76.8 | pg/mL |
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | PAPS | Biomarker IL1B | 3.0 | Standard Deviation 7.7 | pg/mL |
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | SLE/APS | Biomarker IL1B | 11.4 | Standard Deviation 20.1 | pg/mL |
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | Primary aPL | Biomarker IL1B | 0.3 | Standard Deviation 0.6 | pg/mL |
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | SLE/aPL | Biomarker IL1B | 0.5 | Standard Deviation 5.1 | pg/mL |
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | PAPS | Biomarker IL8 | 24.5 | Standard Deviation 48.4 | pg/mL |
| Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients | SLE/APS | Biomarker IL8 | 27.4 | Standard Deviation 53.7 | pg/mL |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PAPS | 18 | |
| Overall Study | STARTED | SLE/APS | 7 | |
| Overall Study | STARTED | Primary aPL | 9 | |
| Overall Study | STARTED | SLE/aPL | 7 | |
| Overall Study | COMPLETED | PAPS | 8 | |
| Overall Study | COMPLETED | SLE/APS | 7 | |
| Overall Study | COMPLETED | Primary aPL | 5 | |
| Overall Study | COMPLETED | SLE/aPL | 4 | |
| Overall Study | NOT COMPLETED | PAPS | 10 | |
| Overall Study | NOT COMPLETED | SLE/APS | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events7
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 | Arthralgia | Musculoskeletal and connective tissue disorders | aPL Positive Patients | 1 | 41 | 1 |
| other | Lupus flare | Immune system disorders | aPL Positive Patients | 1 | 41 | 1 |
| other | Myalgia with high CPK | Musculoskeletal and connective tissue disorders | aPL Positive Patients | 1 | 41 | 1 |
| other | Myalgia with normal CPK | Musculoskeletal and connective tissue disorders | aPL Positive Patients | 3 | 41 | 3 |
| other | Recurrent deep vein thrombosis | Vascular disorders | aPL Positive Patients | 1 | 41 | 1 |
| other | Headache | Nervous system disorders | aPL Positive Patients | 1 | 41 | 1 |
| other | Insomnia | Psychiatric disorders | aPL Positive Patients | 1 | 41 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | aPL Positive Patients | 0 | 41 |
| Total, other adverse events | aPL Positive Patients | 8 | 41 |
| Total, serious adverse events | aPL Positive Patients | 0 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23933625 | BACKGROUND |
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 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/NCT00674297
GET https://conductscience.org/api/trials/v1/NCT00674297/results?page=2