Trial Outcomes & Findings for The Intra-arterial Vasospasm Trial (NCT NCT01996436)
NCT ID: NCT01996436
Last Updated: 2025-05-11
Results Overview
Post infusion improvement ratio (PIIR) = ((B - A) / A) \*100 A = pre-infusion blood vessel diameter B = post infusion blood vessel diameter
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusion
Results posted on
2025-05-11
Participant Flow
Of 92 enrolled participants, 91 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Nicardipine
Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
Nicardipine: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Verapamil
Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
Verapamil: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Nicardipine + Verapamil + Nitroglycerin
Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
Nicardipine + Verapamil + Nitroglycerin: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
29
|
|
Overall Study
Received Intervention
|
32
|
30
|
29
|
|
Overall Study
COMPLETED
|
32
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Intra-arterial Vasospasm Trial
Baseline characteristics by cohort
| Measure |
Nicardipine
n=32 Participants
Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
Nicardipine: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Verapamil
n=30 Participants
Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
Verapamil: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Nicardipine + Verapamil + Nitroglycerin
n=29 Participants
Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
Nicardipine + Verapamil + Nitroglycerin: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 13.081 • n=5 Participants
|
50.933 years
STANDARD_DEVIATION 13.769 • n=7 Participants
|
50.482 years
STANDARD_DEVIATION 10.796 • n=5 Participants
|
51.164 years
STANDARD_DEVIATION 12.652 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
29 participants
n=5 Participants
|
92 participants
n=4 Participants
|
|
Weight
|
185.082 pounds (lbs)
STANDARD_DEVIATION 50.179 • n=5 Participants
|
166.402 pounds (lbs)
STANDARD_DEVIATION 39.156 • n=7 Participants
|
193.338 pounds (lbs)
STANDARD_DEVIATION 45.524 • n=5 Participants
|
181.554 pounds (lbs)
STANDARD_DEVIATION 45.295 • n=4 Participants
|
|
Height
|
161.667 centimeters
STANDARD_DEVIATION 19.527 • n=5 Participants
|
167.674 centimeters
STANDARD_DEVIATION 8.741 • n=7 Participants
|
169.889 centimeters
STANDARD_DEVIATION 8.801 • n=5 Participants
|
166.267 centimeters
STANDARD_DEVIATION 13.570 • n=4 Participants
|
|
Number of Participants with history of hypertension
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Number of Participants with history of diabetes mellitus 1 or 2
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Number of participants with morbid obesity
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Smoking History
Current Smoker
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Smoking History
Non-Smoker
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Smoking History
Past Smoker
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Smoking History
Unknown
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Alcohol History
Habitual Alcoholic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Alcohol History
Social Drinker
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Alcohol History
Teetotaler
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Alcohol History
Unknown
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Substance Abuse History
Cocaine
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Substance Abuse History
Heroin
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Substance Abuse History
Crystal Meth
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Substance Abuse History
Cannabis
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Substance Abuse History
Prescription Drugs
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Substance Abuse History
No Substance abuse
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Substance Abuse History
Unknown
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Number of Participants with History of Hypercholesterolemia
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: pre pharmacological angioplasty blood vessel diameter - 0 min, post pharmacological angioplasty blood vessel diameter- 10 min after infusionPost infusion improvement ratio (PIIR) = ((B - A) / A) \*100 A = pre-infusion blood vessel diameter B = post infusion blood vessel diameter
Outcome measures
| Measure |
Nicardipine
n=18 Participants
Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
Nicardipine: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Verapamil
n=24 Participants
Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
Verapamil: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Nicardipine + Verapamil + Nitroglycerin
n=17 Participants
Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
Nicardipine + Verapamil + Nitroglycerin: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
|---|---|---|---|
|
Post Infusion Improvement Ratio (PIIR)
30% to 50%
|
10 Participants
|
14 Participants
|
8 Participants
|
|
Post Infusion Improvement Ratio (PIIR)
Below 30%
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Post Infusion Improvement Ratio (PIIR)
51% to 70%
|
1 Participants
|
6 Participants
|
5 Participants
|
|
Post Infusion Improvement Ratio (PIIR)
Above 70%
|
3 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 months post discharge from hospitalPopulation: 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.
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.
Outcome measures
| Measure |
Nicardipine
n=30 Participants
Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
Nicardipine: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Verapamil
n=30 Participants
Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
Verapamil: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Nicardipine + Verapamil + Nitroglycerin
n=24 Participants
Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
Nicardipine + Verapamil + Nitroglycerin: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
|---|---|---|---|
|
Disability or Dependence in Daily Activities as Assessed by the Modified Rankin Score
|
1.967 score on a scale
Standard Deviation 1.771
|
1.759 score on a scale
Standard Deviation 1.455
|
2.167 score on a scale
Standard Deviation 2.140
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 day prior to procedure & 1 day after the procedureIntra-cranial pressure will be measured 1 day prior to vasospasm treatment and 1 day after vasospasm treatment
Outcome measures
Outcome data not reported
Adverse Events
Nicardipine
Serious events: 4 serious events
Other events: 21 other events
Deaths: 2 deaths
Verapamil
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Nicardipine + Verapamil + Nitroglycerin
Serious events: 5 serious events
Other events: 27 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Nicardipine
n=32 participants at risk
Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
Nicardipine: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Verapamil
n=31 participants at risk
Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
Verapamil: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Nicardipine + Verapamil + Nitroglycerin
n=29 participants at risk
Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
Nicardipine + Verapamil + Nitroglycerin: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
|---|---|---|---|
|
General disorders
Poor prognosis leading to death
|
3.1%
1/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
6.9%
2/29 • Up to 3 months
|
|
Nervous system disorders
Subarachnoid hemorrhage leading to death
|
3.1%
1/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
0.00%
0/29 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure secondary to Subarachnoid hemorrhage leading to death
|
0.00%
0/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
3.4%
1/29 • Up to 3 months
|
|
Nervous system disorders
Elevated Intracranial Pressure
|
0.00%
0/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
3.4%
1/29 • Up to 3 months
|
|
Nervous system disorders
Intracranial Hemorrhage
|
3.1%
1/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
0.00%
0/29 • Up to 3 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
3.4%
1/29 • Up to 3 months
|
|
Nervous system disorders
recurrent subarachnoid hemorrhage
|
3.1%
1/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
0.00%
0/29 • Up to 3 months
|
Other adverse events
| Measure |
Nicardipine
n=32 participants at risk
Group 1 : Nicardipine 5mg per circulation intra-arterial injection, Pharmacological angioplasty
Nicardipine: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Verapamil
n=31 participants at risk
Group 3: Verapamil 10mg per circulation intra-arterial injection, Pharmacological angioplasty
Verapamil: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
Nicardipine + Verapamil + Nitroglycerin
n=29 participants at risk
Group 4 : Nicardipine 5mg + Verapamil 10mg + Nitroglycerin 200mcg in 4cc 5 % dextrose in water , intra-arterial injection, Pharmacological angioplasty
Nicardipine + Verapamil + Nitroglycerin: Pharmacological angioplasty: intra-arterial drug infusion via catheter to treat cerebral vasospasm
|
|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
3.4%
1/29 • Number of events 1 • Up to 3 months
|
|
Blood and lymphatic system disorders
Acute Posthemorrhagic Anemia
|
0.00%
0/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
3.4%
1/29 • Number of events 1 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
6.2%
2/32 • Number of events 2 • Up to 3 months
|
6.5%
2/31 • Number of events 2 • Up to 3 months
|
13.8%
4/29 • Number of events 4 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
3.1%
1/32 • Number of events 1 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
0.00%
0/29 • Up to 3 months
|
|
Nervous system disorders
Cerebral Spinal Fluid Leak
|
3.1%
1/32 • Number of events 1 • Up to 3 months
|
3.2%
1/31 • Number of events 1 • Up to 3 months
|
3.4%
1/29 • Number of events 1 • Up to 3 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.1%
1/32 • Number of events 1 • Up to 3 months
|
3.2%
1/31 • Number of events 1 • Up to 3 months
|
3.4%
1/29 • Number of events 1 • Up to 3 months
|
|
Blood and lymphatic system disorders
Dry Gangrene
|
0.00%
0/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
3.4%
1/29 • Number of events 1 • Up to 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
9.4%
3/32 • Number of events 3 • Up to 3 months
|
3.2%
1/31 • Number of events 1 • Up to 3 months
|
13.8%
4/29 • Number of events 4 • Up to 3 months
|
|
Nervous system disorders
Elevated Intracranial Pressure
|
3.1%
1/32 • Number of events 1 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
0.00%
0/29 • Up to 3 months
|
|
Immune system disorders
Fever
|
6.2%
2/32 • Number of events 2 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
0.00%
0/29 • Up to 3 months
|
|
Nervous system disorders
Hydrocephalus
|
9.4%
3/32 • Number of events 3 • Up to 3 months
|
19.4%
6/31 • Number of events 6 • Up to 3 months
|
13.8%
4/29 • Number of events 4 • Up to 3 months
|
|
Renal and urinary disorders
Hyponatremia
|
9.4%
3/32 • Number of events 3 • Up to 3 months
|
3.2%
1/31 • Number of events 1 • Up to 3 months
|
10.3%
3/29 • Number of events 3 • Up to 3 months
|
|
Nervous system disorders
Intracranial Hemorrhage
|
3.1%
1/32 • Number of events 1 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
3.4%
1/29 • Number of events 1 • Up to 3 months
|
|
Cardiac disorders
Aysymptomatic NSTEMI
|
0.00%
0/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
3.4%
1/29 • Number of events 1 • Up to 3 months
|
|
Infections and infestations
Periorbital Edema
|
3.1%
1/32 • Number of events 1 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
0.00%
0/29 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.1%
1/32 • Number of events 1 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
10.3%
3/29 • Number of events 3 • Up to 3 months
|
|
Gastrointestinal disorders
Positive Culture
|
0.00%
0/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
3.4%
1/29 • Number of events 1 • Up to 3 months
|
|
Vascular disorders
Pseudoaneurysm
|
0.00%
0/32 • Up to 3 months
|
3.2%
1/31 • Number of events 1 • Up to 3 months
|
0.00%
0/29 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
3.1%
1/32 • Number of events 1 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
0.00%
0/29 • Up to 3 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/32 • Up to 3 months
|
0.00%
0/31 • Up to 3 months
|
3.4%
1/29 • Number of events 1 • Up to 3 months
|
|
Nervous system disorders
Subconjunctival Hemorrhage
|
0.00%
0/32 • Up to 3 months
|
3.2%
1/31 • Number of events 1 • Up to 3 months
|
0.00%
0/29 • Up to 3 months
|
Additional Information
Peng Roc Chen, MD
The University of Texas Health Science Center at Houston
Phone: 713-486-8016
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place