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

University Hospital Maggiore della Carità of Novara

Status and phase: Completed; Phase 3

Conditions: Coronary Angioplasty

Treatments: Drug: Placebo; Drug: Adenosine

Study type: Interventional

Funder types: Other

Identifiers

NCT01148147

2009-013681-92 (Registry Identifier)

CE 93/09

Details and patient eligibility

About

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

Full 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.

Enrollment: 260 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Intracoronary Placebo administration

Treatment:

Drug: Placebo

Adenosine

Active Comparator group

Description:

Intracoronary adenosine administration

Treatment:

Drug: Adenosine