The aim of the present study is a performance evaluation of INNOVANCE® PFA P2Y. The first objective is the determination of a reference interval for the Intended Use Population (patients eligible for Clopidogrel therapy). This will be done by…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints
1) The magnitude of baseline (or intrinsic) platelet reactivity (reflected by
the closure time) among patients who are scheduled for PCI as measured with the
INNOVANCE® PFA P2Y
2) The magnitude of *on-clopidogrel platelet reactivity* (reflected by the
closure time) among patients who are scheduled for PCI as measured with the
INNOVANCE® PFA P2Y
Secondary outcome
1) The magnitude of baseline (or intrinsic) platelet reactivity (among patients
who are scheduled for PCI as measured with LTA, WBA and VASP
2) The magnitude of *on-clopidogrel platelet reactivity* among patients who are
scheduled for PCI as measured with LTA, WBA and VASP
Background summary
Multiple studies have demonstrated that subgroups of patients receiving
combination therapy with aspirin and clopidogrel fail to produce the
anticipated anti-platelet effect and various terms like *aspirin-resistance*,
*clopidogrel resistance* and *heightened post-treatment platelet reactivity*
have been introduced in the medical literature.
Light transmittance aggregometry (LTA) is generally considered to be the gold
standard for determining platelet function, but its relevance to in vivo
platelet function is questionable and the logistical demands of the method make
it impossible to use in daily practice. The INNOVANCE® PFA P2Y cartridge has
been designed to monitor clopidogrel therapy, The aim of the present study is a
performance evaluation of INNOVANCE® PFA P2Y.
Study objective
The aim of the present study is a performance evaluation of INNOVANCE® PFA P2Y.
The first objective is the determination of a reference interval for the
Intended Use Population (patients eligible for Clopidogrel therapy). This will
be done by calculating the 90% central interval of the INNOVANCE® PFA P2Y
results obtained before the intake of the drug (see chapter 4.6). Of note, it
is already known that INNOVANCE® PFA P2Y is not affected by Aspirin®.
The second objective is the derivation of a cut-off (a certain P2Y Closure
Time) for the detection of receptor blockade after loading dose administration.
Calculation of the cut-off will be performed by ROC analysis as explained in
detail in chapter 4.6. Alternatively the cut-off will be calculated as the
upper limit of the reference range of the Intended Use Population
The third objective is the evaluation of the agreement between results obtained
with INNOVANCE® PFA P2Y and results obtained with well-established platelet
aggregometry methods such a light transmittance aggregometry (LTA) and
whole-blood aggregometry (WBA) as well as the flow cytometric VASP assay
The fourth objective is a comparison between INNOVANCE® PFA P2Y results using
blood samples collected in 3.2% and 3.8% buffered sodium citrate. The fourth
objective is a comparison between INNOVANCE® PFA P2Y results using blood
samples collected in 3.2% and 3.8% buffered sodium citrate. For this, blood
samples will be collected in both citrate concentrations (see paragraph 3.4)
and measured as described in paragraph 4.5.
Study design
Observational multicenter cohort study
Study burden and risks
no risks are associated with participation in this study
Emil-von-Behring Str. 76
35041 Marburg, Germany
DE
Emil-von-Behring Str. 76
35041 Marburg, Germany
DE
Listed location countries
Age
Inclusion criteria
•>=18 years of age (18 to 90)
•Documented history of vascular disease
•Eligible to receive clopidogrel
•Indication for clopidogrel (scheduled coronary intervention with stent implantation)
• scheduled for elective coronary stent implantation
•Able to provide written, informed consent in accordance with the IRB (internal review board or ethics committee) and agree to comply with all protocol-specified procedures
Exclusion criteria
• <18 years of age
• Treatment with any drug inhibiting platelet function, such as GPIIb/IIIa inhibitors, ticlopidine or dipyridamole, but not acetylsalicylic acid (Aspirin®) or clopidogrel
• Known inherited or acquired platelet function disorder
• Known inherited or acquired von Willebrand disease
• Pathological CT with PFA ADP Cartridge (3.2% citrate) before intake of clopidogrel
• Current participation in another trial with a substance known to affect platelet function or any investigational new drug
• Platelet count < 150 x109/L to avoid interferences for LTA
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30696.100.09 |