Trial Outcomes & Findings for Study With Aminophylline to Attenuate of the Side Effects of Regadenoson (NCT NCT01250496)
NCT ID: NCT01250496
Last Updated: 2023-03-13
Results Overview
Patients will be surveyed for these symptoms following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
248 participants
Primary outcome timeframe
within 2 hours from the intervention.
Results posted on
2023-03-13
Participant Flow
Recruitment took place at the stress testing laboratories of Rush University Medical Center in the period from November 23, 2010 through February 10, 2011.
Two consenting subjects did not undergo regadenoson-stress for a clinical reason and were subsequently excluded. Otherwise, the remainder of connecting patients received the intervention they are allocated to, completed follow-up and analyzed within the group they were randomized to.
Participant milestones
| Measure |
Aminophylline
75 mg of intravenous aminophylline.
|
Placebo
Matching normal saline placebo (sterile salt water).
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
124
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
124
|
124
|
Reasons for withdrawal
| Measure |
Aminophylline
75 mg of intravenous aminophylline.
|
Placebo
Matching normal saline placebo (sterile salt water).
|
|---|---|---|
|
Overall Study
Study terminated
|
124
|
124
|
Baseline Characteristics
Study With Aminophylline to Attenuate of the Side Effects of Regadenoson
Baseline characteristics by cohort
| Measure |
Aminophylline
n=124 Participants
75 mg of intravenous aminophylline.
|
Placebo
n=124 Participants
Matching normal saline placebo (sterile salt water).
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
71 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
124 participants
n=5 Participants
|
124 participants
n=7 Participants
|
248 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 2 hours from the intervention.Population: All enrolled patients who received the intervention (n=248; 124 aminophylline ans 124 placebo).
Patients will be surveyed for these symptoms following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory.
Outcome measures
| Measure |
Aminophylline
n=124 Participants
75 mg of intravenous aminophylline.
|
Placebo
n=124 Participants
Matching normal saline placebo (sterile salt water).
|
|---|---|---|
|
Composite Endpoints of Abdominal Cramps and Diarrhea.
|
11 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: within 2 hours from the intervention.Population: All enrolled patients who received the intervention (n= 248; 124 aminophyllineand and 124 placebo).
The secondary end-point encompasses any one (or more) regadenoson-related side effects of flushing /feeling hot, chest pain /chest discomfort, angina, headache, dizziness, abdominal cramps/discomfort, diarrhea, and/or nausea. If multiple side effects occur only one side effect is counted.
Outcome measures
| Measure |
Aminophylline
n=124 Participants
75 mg of intravenous aminophylline.
|
Placebo
n=124 Participants
Matching normal saline placebo (sterile salt water).
|
|---|---|---|
|
"Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects.
|
55 participants
|
83 participants
|
Adverse Events
Aminophylline
Serious events: 0 serious events
Other events: 55 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aminophylline
n=124 participants at risk
75 mg of intravenous aminophylline.
|
Placebo
n=124 participants at risk
Matching normal saline placebo (sterile salt water).
|
|---|---|---|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
|
General disorders
Hospitalization
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
|
Nervous system disorders
Seizure
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
Other adverse events
| Measure |
Aminophylline
n=124 participants at risk
75 mg of intravenous aminophylline.
|
Placebo
n=124 participants at risk
Matching normal saline placebo (sterile salt water).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Flushing
|
5.6%
7/124 • Number of events 7 • 24 hours
Clinically determined adverse events that require treatment
|
4.8%
6/124 • Number of events 6 • 24 hours
Clinically determined adverse events that require treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.3%
14/124 • Number of events 14 • 24 hours
Clinically determined adverse events that require treatment
|
18.5%
23/124 • Number of events 23 • 24 hours
Clinically determined adverse events that require treatment
|
|
Nervous system disorders
Headache
|
7.3%
9/124 • Number of events 9 • 24 hours
Clinically determined adverse events that require treatment
|
25.0%
31/124 • Number of events 31 • 24 hours
Clinically determined adverse events that require treatment
|
|
Cardiac disorders
Chest discomfort or pain
|
10.5%
13/124 • Number of events 13 • 24 hours
Clinically determined adverse events that require treatment
|
12.1%
15/124 • Number of events 15 • 24 hours
Clinically determined adverse events that require treatment
|
|
Cardiac disorders
Angina
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
0.00%
0/124 • 24 hours
Clinically determined adverse events that require treatment
|
|
Skin and subcutaneous tissue disorders
Feeling hot
|
8.9%
11/124 • Number of events 11 • 24 hours
Clinically determined adverse events that require treatment
|
9.7%
12/124 • Number of events 12 • 24 hours
Clinically determined adverse events that require treatment
|
|
Gastrointestinal disorders
Nausea
|
16.9%
21/124 • Number of events 21 • 24 hours
Clinically determined adverse events that require treatment
|
17.7%
22/124 • Number of events 22 • 24 hours
Clinically determined adverse events that require treatment
|
|
Gastrointestinal disorders
Abdominal cramp or discomfort
|
8.1%
10/124 • Number of events 10 • 24 hours
Clinically determined adverse events that require treatment
|
13.7%
17/124 • Number of events 17 • 24 hours
Clinically determined adverse events that require treatment
|
|
Nervous system disorders
Dizziness
|
25.0%
31/124 • Number of events 31 • 24 hours
Clinically determined adverse events that require treatment
|
36.3%
45/124 • Number of events 45 • 24 hours
Clinically determined adverse events that require treatment
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
4/124 • Number of events 4 • 24 hours
Clinically determined adverse events that require treatment
|
10.5%
13/124 • Number of events 13 • 24 hours
Clinically determined adverse events that require treatment
|
|
Injury, poisoning and procedural complications
Open label aminophylline use
|
0.81%
1/124 • Number of events 1 • 24 hours
Clinically determined adverse events that require treatment
|
5.6%
7/124 • Number of events 7 • 24 hours
Clinically determined adverse events that require treatment
|
|
Cardiac disorders
Atrial fibrillation
|
0.81%
1/124 • Number of events 1 • 24 hours
Clinically determined adverse events that require treatment
|
0.81%
1/124 • Number of events 1 • 24 hours
Clinically determined adverse events that require treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.81%
1/124 • Number of events 1 • 24 hours
Clinically determined adverse events that require treatment
|
0.81%
1/124 • Number of events 1 • 24 hours
Clinically determined adverse events that require treatment
|
|
Cardiac disorders
Non-sustained ventricular tachycardia
|
0.81%
1/124 • Number of events 1 • 24 hours
Clinically determined adverse events that require treatment
|
0.81%
1/124 • Number of events 1 • 24 hours
Clinically determined adverse events that require treatment
|
Additional Information
Dr. Rami Doukky; Director of Nuclear Cardiology
Rush University Medical Center
Phone: 312-942-4655
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place