UTILIZZO DELLA BIVALIRUDINA PIU' IMPIANTO DI STENT IN LESIONI CORONARICHE LUNGHE NEL PREVENIRE LA MIONECROSI PERIPROCEDURALE

BIVALIRUDIN PLUS STENTING IN lONG LESION TO AVOID PERIPROCEDURAL MYOCARDIAL NECROSIS TRIAL. BILLION TRIAL - BILLION TRIAL

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001952-20-IT

Enrollment

204

Registered

2012-12-19

Start date

2012-12-14

Completion date

Unknown

Last updated

2014-01-27

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

Conditions

patients with coronary artery disease after stent implantation in coronary long lesions (>25 mm) and undergoing non urgent percutaneous coronary intervention. MedDRA version: 14.1 Level: PT Classification code 10011089 Term: Coronary artery stenosis System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: ANGIOX*EV 10F 250MG Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: BIVALIRUDIN CAS Number: 128270-60-0 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: sign informed consent; age>18 years; patients with stable or unstable angina pectoris; de novo lesion with total lenght >25 mm; Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 154

Exclusion criteria

Exclusion criteria: serum creatinine>2,5 mg/dl; pregnancy; ST elevation myocardial infarction; ongoing serious bleeding; previous stroke;Hemodynamic instability

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and efficacy of routine usage of the bivalirudin vs Heparin to avoid periprocedural myocardial necrosis.;Secondary Objective: Rate of major adverse cerebro-cardiovascular events, major and minor bleeding at 1, 6 and 12 months.;Primary end point(s): to value the incidence of periprocedural myonecrosis defined as a peak postprocedural CK.MB elevation>1 time the upper limit of normal, alone or associated with chest pain or ST segment or T wave abnormalities, in patients undergoing non urgent percutaneous myocardial revascularization.;Timepoint(s) of evaluation of this end point: 6, 12 and 24 hours after the rivascolarization procedure.	—

Measure

Time frame

Main Objective: To assess the safety and efficacy of routine usage of the bivalirudin vs Heparin to avoid periprocedural myocardial necrosis.;Secondary Objective: Rate of major adverse cerebro-cardiovascular events, major and minor bleeding at 1, 6 and 12 months.;Primary end point(s): to value the incidence of periprocedural myonecrosis defined as a peak postprocedural CK.MB elevation>1 time the upper limit of normal, alone or associated with chest pain or ST segment or T wave abnormalities, in patients undergoing non urgent percutaneous myocardial revascularization.;Timepoint(s) of evaluation of this end point: 6, 12 and 24 hours after the rivascolarization procedure.

—

Secondary

Measure	Time frame
Secondary end point(s): Rate of major adverse cerebro-cardiovascular events, major and minor bleeding at 1, 6 and 12 months.;Timepoint(s) of evaluation of this end point: 30 days, 6 and 12 months	—

Countries

Italy

Contacts

Public ContactU.O. EMODINAMICA

POLICLINICO UMBERTO I

rino.sardella@uniroma1.it0649979044

Outcome results

None listed

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