The objective for this trial is to evaluate an invasive strategy using urgent PCI (
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be:
Size of MI during initial hospitalization as measured by the AUC of CK-MB.
Secondary outcome
The secondary endpoints of this trial are:
- Size of MI during initial hospitalization as measured by the AUC of CK-MB for
the subpopulation of patients treated with PCI
- The composite endpoint of death, MI and unplanned revascularization at 30 days
- The composite endpoint of MI and major haemorrhage
- Incidence of major haemorrhage up to 30 days
- Incidence of minor haemorrhage up to 30 days
- Incidence of individual and composite endpoints at 30 days and 6 and 12
months including recurrent NSTE-ACS
- Any revascularisation and/or restenosis (TVR) up to 6 months
- Re-hospitalisation because of coronary artery disease (CAD)
Several prespecified sub-analyses will be performed.
- Time of hospitalization
- Hospital costs
- Size of MI during initial hospitalization as measured by the AUC of hsTnT
- Size of MI during initial hospitalization as measured by the AUC of hsTnT for
the subpopulation of patients treated with PCI.
- Comparison of left ventricular function will be performed using longitudinal
strain measurements as derived by 2D echocardiography
- Change in left ventricular function as assessed by using longitudinal strain
measurements between the groups will be evaluated.
- The specificity of NT-proBNP for MI will be evaluated when using hsTnT samples
- The multimarker approach using hsTnT, NT-proBNP and CRP will be evaluated
with regard to the prediction of clinical events
Background summary
The question when to perform PCI in patients with NSTE-ACS has been the subject
of much discussion for patients with non-ST elevated acute coronary syndrom.
Among initially stabilized patients optimal timing of angiography had not been
well defined. The last few years several studies have evaluated the influence
of timing of intervention in these patients. However, comparison of data and
interpretation of the results are difficult, mainly due to methodological
differences between the studies.
Findings from previous trials suggest that angiography performed within 72
hours after admittance is associated with a lower re-mi rate. Still they do not
provide support for undertaking a race against time to perform angiography, as
is justified in STEMI cases.
The time-event relationship with ACS could therefore take the form of a *U*
shaped curve, with very short and very long times to angiography posing a risk.
However, previous trials are conducted with earlier generations of antiplatelet
therapy. Since now there is a novel antiplatelet therapy which is acting faster
and stronger the so called "U" shape might not be accurate anymore. Novel
antiplatelet therapy, such as ticagrelor, is acting faster tot passificate the
coronary plaque, so PCI for patients with ST-elevated myocardial infarction
could be performed earlier without the risk of increase in periprocedural
complications.
This current trial is designed to evaluate the protective effect of the current
generation antiplatelet therapy, in combination with other modern
anticoaglulants which are used as standard of care in patients admitted with a
non-ST elevated myocardial infarction.
Study objective
The objective for this trial is to evaluate an invasive strategy using urgent
PCI (<3h) as compared to an early PCI (24h) using novel quick acting
antiplatelet therapy.
Study design
This is a randomised, prospective, open-label and single center study, for
patients admitted to the hospital with the diagnosis of a non-ST elevation
myocardial infarction. The additional procedures are according to the standard
methods of percutaneous coronary intervention.
Intervention
Revascularisation (where necessary) by percutaneous coronary revascularisation:
Randomised to either "urgent" (<3 uur) or "early" (12-24 uur) angiography/PCI.
Study burden and risks
It is unclear whether urgent angiography and PCI for patients with non-ST
elevated myocardial infarction after they received Ticagrelor will lead to
better (clinical) outcomes. However, by making use of novel antiplatelet
therapy this theory is plausible, as is described above. Currently there are no
trials showing that this group of patients benefit by urgent revascularisation.
Because of this it might be possible that patients will not benefit or urgent
revascularisation will even have a negative effect on patients (clinical)
outcome.
Patient who will participate in OPTIMA-2 will undergo additional bloodsampling
during hospitalization as compared to patients who do not participate.
The study includes three extra outpatient visits for study purposes.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
- Age > 21 years
- Typical chest pain for angina pectoris lasting at least 10 minutes, within
the
last 24 hours
- No contra-indication to PCI
- And at least one of the following criteria:
1. 1 mm of horizontal or downsloping ST depression
2. Dynamic ST- or T- wave changes > 1 mm in two contiguous leads
3. Elevated hs troponin (>1xULN)
4. Known coronary artery disease
5. Two of following risk factors: DM, known hypertension, current smoking,
family history for ischemic heart disease, hypercholesterolemia, peripheral
artery disease, age over 60 years.
Exclusion criteria
- Acute ST myocardial infarction
- Refractory angina
- Severe heart failure
- Life-threatening ventricular arrhythmias
- Haemodynamic instability
- Contraindication for the use of Ticagrelor
- Participation in another study
- Use of oral anticoagulants
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 | NL41414.100.12 |