Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging (ASSUAGE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rami Doukky, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01250496
First received: November 29, 2010
Last updated: November 27, 2012
Last verified: November 2012

November 29, 2010
November 27, 2012
November 2010
September 2011   (final data collection date for primary outcome measure)
Composite endpoints of abdominal cramps and diarrhea. [ Time Frame: within 2 hours from the intervention. ] [ Designated as safety issue: No ]
Patients will be surveyed for these symptoms following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory.
Same as current
Complete list of historical versions of study NCT01250496 on ClinicalTrials.gov Archive Site
Global symptomatic burden of regadenoson [ Time Frame: within 2 hours from the intervention. ] [ Designated as safety issue: No ]
Secondary end-point encompasses the sum of all regadenoson-related adverse-events of flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea, bronchospasm and the need to administer a clinically indicated aminophylline to treat suspected regadenoson related side effects.
Same as current
Not Provided
Not Provided
 
Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging
Attenuation of the Side Effect Profile of Regadenoson: A Randomized Double-Blind Placebo Controlled Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging.

The routine administration of 75 mg of intravenous aminophylline following regadenoson (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce the gastrointestinal (diarrhea and stomach upset) and other side effects related to regadenoson.

Approximately 250 patients who are referred for a nuclear stress testing of the heart with regadenoson (Lexiscan®) will be recruited to participate in the study. Following regadenoson (administered as part of a stress routine test protocol) participants will receive either aminophylline (75 mg - intravenously) or a matching inactive placebo (sterile salt water) injection. Participants will be surveyed for gastrointestinal symptoms and other side effects related to regadenoson. The frequency and severity of such side effects will be compared between the two study groups (aminophylline vs. placebo).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson (Lexiscan ®).
  • Drug: Aminophylline
    75 mg of intravenous aminophylline
  • Drug: Placebo
    Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
  • Experimental: Aminophylline
    75 mg of intravenous aminophylline.
    Intervention: Drug: Aminophylline
  • Placebo Comparator: Placebo
    Matching normal saline placebo (sterile salt water).
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
248
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients referred to undergo a clinically-indicated regadenoson-stress myocardial perfusion imaging at Rush University Medical Center

Exclusion Criteria:

  • Patient refusal to participate
  • Known allergic reaction to aminophylline.
  • Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea, abdominal discomfort, nausea or vomiting.
  • Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and acute coronary symptoms.
  • Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12 months or any seizure in the past week.
  • Pregnant or breast-feeding women.
  • Patients receiving anti-platelet agent dipyridamole (Persantine® or Aggrenox®).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01250496
ASSUAGETrial
Yes
Rami Doukky, Rush University Medical Center
Rush University Medical Center
Not Provided
Not Provided
Rush University Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP