Optimal Timing of Coronary Intervention in Unstable Angina 2

Optimal Timing of Coronary Intervention in Unstable Angina 2 - OPTIMA 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36977

Enrollment

350

Registered

2012-12-21

Start date

2012-06-01

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

heart attack myocardial infarction

Interventions

Revascularisation (where necessary) by percutaneous coronary revascularisation: Randomised to either "urgent" (

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The primary endpoint will be: Size of MI during initial hospitalization as measured by the AUC of CK-MB.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)