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Safety and Efficacy Study of Clevidipine to Control Hypertension in Patients Admitted With Aneurysmal Subarachnoid Hemorrhage (CLASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00978822
Recruitment Status : Terminated (Difficult enrollment parameters, subsequently low enrollment. Decision to terminate trial.)
First Posted : September 17, 2009
Results First Posted : February 28, 2023
Last Update Posted : March 2, 2023
Sponsor:
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
Panayiotis Varelas, Henry Ford Health System

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Subarachnoid Hemorrhage
Hypertension
Intervention Drug: Clevidipine butyrate injectable emulsion
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clevidipine
Hide Arm/Group Description Single arm, all patients were receiving clevidipine
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Clevidipine Butyrate Injectable Emulsion
Hide Arm/Group Description Clevidipine butyrate injectable emulsion: Clevidipine butyrate injectable emulsion infusion starting at 2 mg/hour and titrating up for effect till 32 mg/h for up to 24 hours starting in the emergency department and continued in the critical care units.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  80.0%
>=65 years
1
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
56.8  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  40.0%
White
3
  60.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
SBP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 5 participants
146.4  (2.48)
1.Primary Outcome
Title Ability to Control and Maintain Blood Pressure Within a Certain Range by the Drug Infusion.
Hide Description

All patients reached the SBP target after initiation of the first infusion within 14.2 ± 6.4 min (n = 5, range 7-22 min)

Study closed October 2012
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
5 pts received clevidipine
Arm/Group Title Clevidipine
Hide Arm/Group Description:
Single arm, all patients were receiving clevidipine
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: min
14.2  (6.4)
Time Frame [Not Specified]
Adverse Event Reporting Description Possible adverse event: Anaphylactic shock Possible adverse event:Cardiac arrest
 
Arm/Group Title Clevidipine
Hide Arm/Group Description No adverse events
All-Cause Mortality
Clevidipine
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Serious Adverse Events
Clevidipine
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clevidipine
Affected / at Risk (%)
Total   0/5 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Panayiotis Varelas
Organization: Albany Medical Center
Phone: 2488739855
EMail: varelap@amc.edu
Layout table for additonal information
Responsible Party: Panayiotis Varelas, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00978822    
Other Study ID Numbers: CLV-0904-001
PCF Varelas 5605
First Submitted: September 16, 2009
First Posted: September 17, 2009
Results First Submitted: January 31, 2023
Results First Posted: February 28, 2023
Last Update Posted: March 2, 2023