To assess whether the in-laboratory strategy is non-inferior to the preloading strategy in patients planned for diagnostic CAG with optional ad-hoc PCI.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in occurrence of the composite endpoint 'Net Adverse Clinical
Events' (NACE; all-cause death, myocardial infarction, definite/probable stent
thrombosis, stroke and BARC type 2, -3 or -5 bleeding) assessed at 30 days.
Secondary outcome
To assess the difference in :
- Bleeding Academic Research Consortium (BARC) -2, -3 and -5 bleeding
in-hospital and at 30 days
- The composite endpoint 'Patient Oriented Clinical Events' (POCE; all-cause
death, stroke, myocardial infarction, repeat revascularization) in-hospital and
at 30 days
- Individual endpoints of the composite endpoints POCE / NACE in-hospital and
at 30 days
Background summary
In the contemporary national and international practice, two medication
strategies are used for patients that are referred for diagnostic coronary
angiography with optional ad-hoc PCI treatment. The first strategy includes a
pretreatment period of several (3-5) days in which all patients are treated
with a low dose of clopidogrel prior to the procedure (preloading strategy).
Patients treated according to the second strategy, receive a clopidogrel
loading dose in the catheterization laboratory but only after the indication
for ad-hoc PCI is made (in-laboratory loading). The two locations of the
recently merged Amsterdam University Medical Center (AUMC) both use a different
medication strategy in this patient group. With this prospective observational
registry we want to investigate whether the 'in-laboratory' strategy is
non-inferior to the 'preloading' strategy. If clopidogrel preloading could be
omitted in patients referred for diagnostic CAG, then it would lead to a
reduction in unnecessary medication intake, less inconvenience for patients and
lower healthcare costs. This prospective registry will determine the future
policy of the AMC for patients referred for diagnostic CAG.
Study objective
To assess whether the in-laboratory strategy is non-inferior to the preloading
strategy in patients planned for diagnostic CAG with optional ad-hoc PCI.
Study design
A prospective registry.
Intervention
The first group will receive a 600mg loading dose of clopidogrel directly
before start of PCI (in-laboratory group), while the second group will receive
clopidogrel 75mg once daily 3 days before diagnostic coronary angiography with
optional ad-hoc PCI (preloading group).
Study burden and risks
Follow-up data at 30 days will be collected by (telephone) questionnaire. The
risks associated with participation to this registry can be considered
negligible and the burden can be considered minimal, because this study
evaluates outcomes in common practice loading strategies that are already used
in the AUMC.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Adult men and women aged at least 18 years
- Scheduled for diagnostic CAG due to suspected obstructive coronary artery
disease
Exclusion criteria
- Inability to give informed consent (e.g., language barrier)
- Presence of contra-indications for the use of clopidogrel
- Patients using clopidogrel for other reasons than the scheduled diagnostic
CAG
- Patients using P2Y12 inhibitors other than clopidogrel
- Patients using VKA
- Patients using DOAC/NOAC
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 | EUCTR2021-006072-16-NL |
| CCMO | NL79315.018.22 |