To determine if aspiration thrombectomy can reduce the rate of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure in patients with STEMI undergoing primary PCI.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The composite of cardiovascular death, recurrent MI, cardiogenic shock, or new
or worsening NYHA Class IV heart failure at 180 days.
Secondary outcome
1. Stroke at 30 days
2. Cardiovascular death, MI, stroke, cardiogenic shock or new or worsening
class IV heart failure at 1 year
3. Cardiovascular Mortality at 180 days
Background summary
Currently there are no large multi-centre trials for thrombectomy in primary
PCI. The 50% reduction in mortality seen in the TAPAS trial is equal to or
greater than the benefit of primary PCI compared to fibrinolysis, and thus this
finding in a relatively small trial may be due to chance. On the other hand,
the potential for harm is also quite substantial. There is uncertainty amongst
interventional cardiologists as to whether routine thrombectomy in primary PCI
is beneficial.
As a result, a large randomized multi-centre trial is clearly needed to answer
the question whether manual catheter-based thrombectomy can reduce important
adverse events compared to conventional PCI in patients with STEMI undergoing
primary PCI.
Additional background information is available in Section 1 of the Protocol.
Study objective
To determine if aspiration thrombectomy can reduce the rate of cardiovascular
death, recurrent myocardial infarction, cardiogenic shock, or new or worsening
NYHA Class IV heart failure in patients with STEMI undergoing primary PCI.
Study design
This is an international, randomized, controlled, parallel group trial of
routine aspiration thrombectomy with PCI versus PCI alone in patients with
STEMI, randomized within 12 hours of symptoms onset.
Intervention
Routine aspiration thrombectomy followed by PCI
Study burden and risks
None. Patients will undergo routine treatments only.
Population Health Research Institute, 237 Barton St E, DBCVSRI -
Hamilton, Ontario L8L 2X2
CA
Population Health Research Institute, 237 Barton St E, DBCVSRI -
Hamilton, Ontario L8L 2X2
CA
Listed location countries
Age
Inclusion criteria
1. Patients presenting with:
*Symptoms of myocardial ischemia lasting for >= 30 minutes AND
*Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
2.Referred for primary PCI
3.Randomized within 12 hours of symptoms onset and prior to diagnostic angiography
4.Informed consent
Exclusion criteria
1.Age <= 18 years
2.Prior coronary artery bypass surgery (CABG)
3.Life expectancy less than six months due to non-cardiac condition
4.Treatment with fibrinolytic therapy for qualifying index STEMI event
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 |
|---|---|
| ClinicalTrials.gov | NCT01149044 |
| CCMO | NL40543.100.12 |