Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty (PREVENT-ICARUS)

• ClinicalTrials.gov Identifier: NCT01148147
• Recruitment Status: Completed
• First Posted: June 22, 2010
• Last Update Posted: November 8, 2011
• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Information provided by: Azienda Ospedaliero Universitaria Maggiore della Carita

Tracking Information

• First Submitted Date: June 7, 2010
• First Posted Date: June 22, 2010
• Last Update Posted Date: November 8, 2011
• Study Start Date: November 2009
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 21, 2010): Increase in troponin I (> 3 times the upper normal limit) [ Time Frame: At 12 hours after the procedure ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 21, 2010)

• MACE(death, MI, urgent target-vessel revascularization) [ Time Frame: 72 hours ]
• Angiographic Coronary flow, as evaluated by corrected TIMI frame count. [ Time Frame: 1 minute after the final stent implantation ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty
• Official Title: Prevention of Cardiac and Vascular Periprocedural Complications in Patients Undergoing Coronary Angiography or Angioplasty: Intracoronary Adenosine Administration to Prevent Periprocedural Myonecrosis in Elective Coronary Angioplasty. A Prospective Double-blind Randomized Trial.
• Brief Summary: Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.

Detailed Description

This study will investigate the effects of adjunctive intracoronary administration of adenosine on periprocedural myocardial infarction as compared to placebo.

This is a double-blind randomized trial single-center study. The enrollment will last 10 months.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Coronary Angioplasty

Intervention

• Drug: Adenosine
  Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)
• Drug: Placebo
  Intracoronary Placebo administration

Study Arms

• Placebo Comparator: Placebo
  Intracoronary Placebo administration
  Intervention: Drug: Placebo
• Active Comparator: Adenosine
  Intracoronary adenosine administration
  Intervention: Drug: Adenosine

• Publications *: De Luca G, Iorio S, Venegoni L, Marino P. Evaluation of intracoronary adenosine to prevent periprocedural myonecrosis in elective percutaneous coronary intervention (from the PREVENT-ICARUS Trial). Am J Cardiol. 2012 Jan 15;109(2):202-7. doi: 10.1016/j.amjcard.2011.08.027. Epub 2011 Oct 14.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: June 21, 2010): 260
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2010
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients undergoing elective coronary angioplasty

Exclusion Criteria:

Marked Bradycardia (< 40 bpm)

• Previous allergy to adenosine
• Inability to sign the informed consent
• Asthma
• Elevated cardiac enzymes (troponin I o CK-MB)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01148147
• Other Study ID Numbers: CE 93/09; 2009-013681-92 ( Registry Identifier: EUDRACT )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Giuseppe De Luca, MD, PhD, AOU Maggiore della Carita - Eastern Piedmont University
• Study Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Collaborators: Not Provided

Investigators

• Principal Investigator: Giuseppe De Luca, MD; AOU Maggiore della Carità

• PRS Account: Azienda Ospedaliero Universitaria Maggiore della Carita
• Verification Date: September 2010