NCT01148147

Brief Summary

Aim of the study is to evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 8, 2011

Status Verified

September 1, 2010

Enrollment Period

9 months

First QC Date

June 7, 2010

Last Update Submit

November 7, 2011

Conditions

Coronary Angioplasty

Keywords

Adenosinerandomized trialperiprocedural myocardial necrosiselective coronary angioplasty

Outcome Measures

Primary Outcomes (1)

  • Increase in troponin I (> 3 times the upper normal limit)

    At 12 hours after the procedure

Secondary Outcomes (2)

  • MACE(death, MI, urgent target-vessel revascularization)

    72 hours

  • Angiographic Coronary flow, as evaluated by corrected TIMI frame count.

    1 minute after the final stent implantation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Intracoronary Placebo administration

Drug: Placebo

Adenosine

ACTIVE COMPARATOR

Intracoronary adenosine administration

Drug: Adenosine

Interventions

AdenosineDRUG

Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)

Adenosine
PlaceboDRUG

Intracoronary Placebo administration

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective coronary angioplasty

You may not qualify if:

  • Marked Bradycardia (\< 40 bpm)
  • Previous allergy to adenosine
  • Inability to sign the informed consent
  • Asthma
  • Elevated cardiac enzymes (troponin I o CK-MB)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giuseppe De Luca

Novara, 28100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22000773DERIVED

MeSH Terms

Interventions

Adenosine

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Giuseppe De Luca, MD

    AOU Maggiore della Carità

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 22, 2010

Study Start

November 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 8, 2011

Record last verified: 2010-09

Locations

IT(1)