Trial · NCT01996436
The Intra-arterial Vasospasm Trial
NCT01996436, Phase 4, Terminated, Peng Roc Chen, MD; results first posted 2025-05-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Intra-arterial Vasospasm Trial. Trials, record NCT01996436. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01996436
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Intra-arterial Vasospasm Trial
- NCT number
- NCT01996436
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 92 participants, actual
- Lead sponsor
- Peng Roc Chen, MD
- Conditions
- Cerebral Vasospasm
- Interventions
- Nicardipine, Verapamil, Nicardipine + Verapamil + Nitroglycerin
- First posted
- 2013-11-27
- Last updated
- 2025-05-11
- Results first posted
- 2025-05-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post Infusion Improvement Ratio (PIIR) | pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion | Post infusion improvement ratio (PIIR) = ((B - A) / A) \*100 A = pre-infusion blood vessel diameter B = post infusion blood vessel diameter |
| Secondary | Disability or Dependence in Daily Activities as Assessed by the Modified Rankin Score | 3 months post discharge from hospital | The modified Rankin Scale (mRS) is used to assess the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The Modified Rankin Score (mRS) is scored as follows: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
| Other | Intra-cranial Pressure | 1 day prior to procedure & 1 day after the procedure | Intra-cranial pressure will be measured 1 day prior to vasospasm treatment and 1 day after vasospasm treatment |
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 | Post Infusion Improvement Ratio (PIIR) | pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disability or Dependence in Daily Activities as Assessed by the Modified Rankin Score | 3 months post discharge from hospital | Data were not collected from 2 participants from the Nicardipine arm and 5 participants in the Nicardipine + Verapamil + Nitroglycerin arm because the assessment was not administered to them. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Intra-cranial Pressure | 1 day prior to procedure & 1 day after the procedure |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Post Infusion Improvement Ratio (PIIR) | Nicardipine | Below 30% | 4 | Participants | |
| Post Infusion Improvement Ratio (PIIR) | Verapamil | Below 30% | 3 | Participants | |
| Post Infusion Improvement Ratio (PIIR) | Nicardipine + Verapamil + Nitroglycerin | Below 30% | 2 | Participants | |
| Post Infusion Improvement Ratio (PIIR) | Nicardipine | 30% to 50% | 10 | Participants | |
| Post Infusion Improvement Ratio (PIIR) | Verapamil | 30% to 50% | 14 | Participants | |
| Post Infusion Improvement Ratio (PIIR) | Nicardipine + Verapamil + Nitroglycerin | 30% to 50% | 8 | Participants | |
| Post Infusion Improvement Ratio (PIIR) | Nicardipine | 51% to 70% | 1 | Participants | |
| Post Infusion Improvement Ratio (PIIR) | Verapamil | 51% to 70% | 6 | Participants | |
| Post Infusion Improvement Ratio (PIIR) | Nicardipine + Verapamil + Nitroglycerin | 51% to 70% | 5 | Participants | |
| Post Infusion Improvement Ratio (PIIR) | Nicardipine | Above 70% | 3 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nicardipine | 32 | |
| Overall Study | STARTED | Verapamil | 31 | |
| Overall Study | STARTED | Nicardipine + Verapamil + Nitroglycerin | 29 | |
| Overall Study | Received Intervention | Nicardipine | 32 | |
| Overall Study | Received Intervention | Verapamil | 30 | |
| Overall Study | Received Intervention | Nicardipine + Verapamil + Nitroglycerin | 29 | |
| Overall Study | COMPLETED | Nicardipine | 32 | |
| Overall Study | COMPLETED | Verapamil | 30 | |
| Overall Study | COMPLETED | Nicardipine + Verapamil + Nitroglycerin | 29 | |
| Overall Study | NOT COMPLETED | Nicardipine | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events84
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 | Acute Kidney Injury | Renal and urinary disorders | Nicardipine | 0 | 32 | 0 |
| other | Acute Kidney Injury | Renal and urinary disorders | Verapamil | 0 | 31 | 0 |
| other | Acute Kidney Injury | Renal and urinary disorders | Nicardipine + Verapamil + Nitroglycerin | 1 | 29 | 1 |
| other | Acute Posthemorrhagic Anemia | Blood and lymphatic system disorders | Nicardipine | 0 | 32 | 0 |
| other | Acute Posthemorrhagic Anemia | Blood and lymphatic system disorders | Verapamil | 0 | 31 | 0 |
| other | Acute Posthemorrhagic Anemia | Blood and lymphatic system disorders | Nicardipine + Verapamil + Nitroglycerin | 1 | 29 | 1 |
| other | Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Nicardipine | 2 | 32 | 2 |
| other | Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Verapamil | 2 | 31 | 2 |
| other | Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Nicardipine + Verapamil + Nitroglycerin | 4 | 29 | 4 |
| other | COVID-19 | Respiratory, thoracic and mediastinal disorders | Nicardipine | 1 | 32 | 1 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nicardipine | 2 | 32 |
| Total, all-cause mortality | Verapamil | 0 | 31 |
| Total, all-cause mortality | Nicardipine + Verapamil + Nitroglycerin | 3 | 29 |
| Total, other adverse events | Nicardipine | 21 | 32 |
| Total, other adverse events | Verapamil | 13 | 31 |
| Total, other adverse events | Nicardipine + Verapamil + Nitroglycerin | 27 | 29 |
| Total, serious adverse events | Nicardipine | 4 | 32 |
| Total, serious adverse events | Verapamil | 0 | 31 |
| Total, serious adverse events | Nicardipine + Verapamil + Nitroglycerin | 5 | 29 |
Source ClinicalTrials.gov
Papers9
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/NCT01996436
GET https://conductscience.org/api/trials/v1/NCT01996436/events?page=2