Canyon-I-Pilot Trial a dose-ranging study of bolus-only Desirudin in patients undergoing PCI

Canyon-I-Pilot Trial a dose-ranging study of bolus-only Desirudin in patients undergoing PCI - CANYON-PCI pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35683

Enrollment

Registered

2009-07-15

Start date

2009-09-04

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

narrowing of the coronary arteries

Interventions

Patients who participate in this study will receive 1 of the 4 treatment groups administered before the PCI procedure.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The patient is at least 18 years old; The patient is due to undergo an elective PCI on one or multiple lesions in the coronary vessel(s) The patient provided written informed consent

Exclusion criteria

Exclusion criteria: The patient is not a candidate for PCI The patient experienced an acute Myocardial Infarction within previous 4 weeks. The patient has an increased bleeding risk Hemodynamic instability Severe hypertension

Design outcomes

Primary

Measure	Time frame
The primary objective of this trial is to evaluate the change in ultrasensitive troponin within 6-8 hours, 14-16 hours, and 22-24 hours following the index procedure, as a surrogate marker for peri-procedural ischemic events.	—

Secondary

Measure	Time frame
The secondary objectives are to compare: • the combined safety and the preliminary efficacy towards prevention of ischemic events and major bleeding of two doses of Revasc® (Desirudin 30mg, 45mg), as compared to unfractionated heparin (UFH) and Bivalirudin, in addition to a standard dual antiplatelet regimen, in the setting of elective low to medium risk Percutaneous Coronary Intervention (PCI) • the individual components of the primary endpoint, and of other major clinical endpoints; • the safety of the treatments plus dual antiplatelet therapy, particularly with respect to bleeding complications; • clinical signs of thrombosis; • the coagulation profile of two different doses of Desirudin in addition to a standard dual antiplatelet regimen in the setting of elective PCI. • The differential effect of different anticoagulation regimens on neutrophil activation, myeloperoxidase release and systemic inflammation following PCI.	—

Measure

Time frame

The secondary objectives are to compare: • the combined safety and the preliminary efficacy towards prevention of ischemic events and major bleeding of two doses of Revasc® (Desirudin 30mg, 45mg), as compared to unfractionated heparin (UFH) and Bivalirudin, in addition to a standard dual antiplatelet regimen, in the setting of elective low to medium risk Percutaneous Coronary Intervention (PCI) • the individual components of the primary endpoint, and of other major clinical endpoints; • the safety of the treatments plus dual antiplatelet therapy, particularly with respect to bleeding complications; • clinical signs of thrombosis; • the coagulation profile of two different doses of Desirudin in addition to a standard dual antiplatelet regimen in the setting of elective PCI. • The differential effect of different anticoagulation regimens on neutrophil activation, myeloperoxidase release and systemic inflammation following PCI.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)