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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 (PREVENT ICARUS) trial - PREVENT-ICARUS

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 (PREVENT ICARUS) trial - PREVENT-ICARUS

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-013681-92-IT
Enrollment
Unknown
Registered
2009-11-04
Start date
2009-10-29
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective coronary angioplasty MedDRA version: 9.1 Level: SOC Classification code 10047065

Interventions

Trade Name: KRENOSIN Pharmaceutical Form: Solution for injection INN or Proposed INN: Adenosine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 12- Ph

Sponsors

AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing elective coronary angioplasty Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Marked Bradicardia (< 40 bpm). Previous allergy to adenosin. Inability to sign the informed consent. Asthma Elevated cardiac enzymes (troponin I o CK-MB)

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the benefits from adjunctive intracoronary administration of adenosin in elective patients undergoing coronary angioplasty.;Secondary Objective: N.D.;Primary end point(s): Periprocedural troponin I release > 3 times the normal upper limit

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026