A dose-ranging study of bolus-only Desirudin in patients undergoing PCI

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-010903-98-BE

Enrollment

Registered

2009-06-09

Start date

2009-08-20

Completion date

Unknown

Last updated

2014-10-07

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

Conditions

Patients due to undergo an elective (non-urgent) PCI on one or multiple lesions in the native coronary vessel(s) via a femoral approach.

Interventions

Trade Name: Revasc Pharmaceutical Form: Powder and solvent for solution for injection Trade Name: UnFractionated Heparin (UFH) Product Name: Unfractioned heparin Product Code: Unfractioned heparin P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients due to undergo an elective (non-urgent) PCI on one or multiple lesions in the native coronary vessel(s) via a femoral approach; Indication for PCI: stable or unstable angina (without Troponin rise), or silent myocardial ischemia; AND At least 18 years old, Providing written informed consent before initiation of any study related procedures, Being pre-treated with a 600-mg loading dose of clopidogrel and aspirin at least 6 hours before the intervention or on chronic clopidogrel/aspirin treatment 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: Patients are excluded from this study if: ?They passed the upper age limit 85 years, ?Lactating/pregnant women, ?Body weight <40kg, ?Not a candidate for PCI, ?Experienced a Acute Myocardial Infarction within previous 4 weeks; ?Angina Braunwald class A and C, Troponin positive/CK-MB above ULN at screening ?New York Heart Association class III or IV congestive heart failure, ?Hemodynamic instability, ?Severe hypertension, ?Significant valvular disease, ?Increased bleeding risk, ?Use of non-steroidal inflammatory drug (NSAID) within 12h prior to PCI ?Taking part in any other medical study, including its follow-up phase

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and the preliminary efficacy as measured by the frequency of ischemic events and major bleeding of two doses of Revasc (Desirudin 30mg, 45 mg), as compared to either UnFractionated Heparin (UFH) or Bivalirudin, in addition to a standard dual antiplatelet regimen, in the setting of elective low to medium risk Percutaneous Coronary Intervention (PCI).;Secondary Objective: ;Primary end point(s): The 7-day combined incidence of death from any cause, non-fatal myocardial infarction, urgent target vessel revascularization (coronary bypass surgery or PCI) due to myocardial ischemia. In addition, non-CABG major bleeding occurring up to 48 hours after PCI will be assessed.	—

Measure

Time frame

Main Objective: To evaluate the safety and the preliminary efficacy as measured by the frequency of ischemic events and major bleeding of two doses of Revasc (Desirudin 30mg, 45 mg), as compared to either UnFractionated Heparin (UFH) or Bivalirudin, in addition to a standard dual antiplatelet regimen, in the setting of elective low to medium risk Percutaneous Coronary Intervention (PCI).;Secondary Objective: ;Primary end point(s): The 7-day combined incidence of death from any cause, non-fatal myocardial infarction, urgent target vessel revascularization (coronary bypass surgery or PCI) due to myocardial ischemia. In addition, non-CABG major bleeding occurring up to 48 hours after PCI will be assessed.

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Countries

Belgium

Outcome results

None listed

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