1) to investigate if patients on chronic NOAC treatment are sufficiently anticoagulated without additional UFH during CAG/PCI, and 2) if this sufficient anticoagulation can be confirmed pre-procedure by a point-of-care test, and3) to investigate if…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Laboratory measurements
1) APTT, PT
2) Fibrinogen, D-dimer, fibrinopeptide A and B, trombin generation test,
soluble fibrin
3) factor XIIa and kallikrein; XIa, IXa, Xa- in complex with inhibitors and
prothrombin fragment 1+2
4) Anti-Xa
5) Soluble platelet release markers including P-selectin, GpVI, CD40L etc.
6) T-TAS
Point-of-care tests
1) ClotPro IN, HI, RVV, ECA, and NA-tests
2) TEG: global haemostasis assay
3) Activated Clotting Time (ACT)
Secondary outcome
Clinical events related to bleeding or thrombosis at discharge, and after 30
days
Background summary
During coronary angiography and/or percutaneous coronary intervention (PCI)
additional anticoagulation with unfractionated heparin (UFH) is recommended by
international guidelines to prevent catheter thrombosis and thrombotic
complications.1,2 In patients using chronic vitamin K antagonist (VKA)
treatment, the use of peri-procedural UFH, however, is associated with an
increased risk of access site complications after PCI (mainly bleeding),
without benefit in thrombotic complications.3 Bleeding after PCI has been shown
to be related to both short- and long-term mortality4, and thus should be
prevented by minimizing antithrombotic therapy where possible. Therefore, for
patients using VKA with an INR > 2.5 no additional UFH is recommended.1 For
NOACs it is yet unknown if UFH can be omitted, and thus current guidelines
still recommend additional UFH for patients using NOAC.1
Study objective
1) to investigate if patients on chronic NOAC treatment are sufficiently
anticoagulated without additional UFH during CAG/PCI, and
2) if this sufficient anticoagulation can be confirmed pre-procedure by a
point-of-care test, and
3) to investigate if patients treated with chronic NOAC with additional
periprocedural UFH are hypocoaguable during CAG/PCI
To be in the end able to omit periprocedural heparin, to reduce procedure
related bleeding complications
Study design
Randomized controlled trial
Intervention
Group 1 (reference cohort)
40 patients without chronic NOAC treatment undergoing elective CAG or PCI with
peri-procedural UFH
Group 2 (NOAC cohort)
80 patients with chronic NOAC treatment undergoing elective CAG/PCI
1:1 randomized to:
Arm 2a: continuation of NOAC with additional peri-procedural UFH
Arm 2b: continuation of NOAC without additional UFH
Study burden and risks
Blood draws will be taken from a routinely placed IV catheter that also would
be placed during a procedure without study participation. The timing of blood
draws will be within the standard admission duration of 4 hours after PCI. So
with blood sampling there will be no extra burden for the patients apart from
the blood that will be drawn.
Patients participating in group 1 will not have possible benefit since they
serve as reference group. Also their risk is very limited, since only blood
will be drawn.
Patients participating in group 2 would usually be treated following the
guideline recommendations with NOAC plus UFH, if not participating in this
study.
Patients randomized to group 2a will be treated according to this guideline, so
there will not be a possible benefit or risk compared to usual treatment, apart
from that extra blood will be drawn.
Patients randomized to group 2b might have a slight risk of insufficient
anticoagulation since UFH will be withhold compared to the standard treatment.
However, clinical end point data from VKA, and laboratory data with NOACs seem
to indicate that this is safer and equally effective (see study protocol
chapter 1 and Table 1). Also, as in all study patients, extra blood will be
drawn compared to standard treatment.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
Patient must meet all of the following criteria:
- Male or female >= 18 years
- Undergoing non-emergent CAG or PCI
- Loaded with P2Y12 inhibitors before PCI
- Patients with signed informed consent
Exclusion criteria
Patients who fulfill the above mentioned inclusion criteria but who manifest
any of the following exclusion criteria will not be eligible for the study: -
Patients with hematologic, renal (estimated glomerular filtration <30
ml/min/1.73m2), hepatic (liver enzymes >2 times the upper limit of normal),
inflammatory (CRP >2 times the upper limit of normal) or neoplastic disorders -
Patients using nonsteroidal anti-inflammatory drugs, corticosteroids, or
hormone replacement therapy
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2020-005298-29-NL |
| CCMO | NL75820.100.20 |