Condition category
Circulatory System
Date applied
23/01/2007
Date assigned
05/03/2007
Last edited
26/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Joost Haeck

ORCID ID

Contact details

Department of Cardiology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PREPARE

Study hypothesis

The use of the PROXIS™ combined embolic protection and thrombectomy device during primary percutaneous coronary intervention (PCI) leads to a more rapid resolution of ST-segment elevation, to increased thrombolysis in myocardial infarction (TIMI)-graded coronary flow and myocardial blush, to smaller enzymatic infarct-size and is effective in the reduction of distal embolisation compared to standard primary PCI in acute ST-elevation myocardial infarction (MI).

Ethics approval

Approval received from the local ethics committee (Medisch Ethische Commissie (MEC), Academisch Medisch Centrum, Universiteit van Amsterdam) on the 15th July 2005 (ref: MEC 05/168).

Study design

Prospective randomised open trial with blinded evaluation of patient outcomes

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Myocardial infarction

Intervention

Patients with symptoms of acute MI within the previous six hours, persistent ST-elevation and a coronary anatomy suitable for PROXIS™ are randomly assigned to combined embolic protection and thrombectomy with PROXIS™, or standard PCI.

All patients receive:
1. Acetylsalicylic acid (300 mg)
2. Clopidogrel at a starting dose of 600 mg
3. Unfractionated heparin (70 U/kg)
Abciximab can be given at any time of the procedure, at the discretion of the operator.

PCI of the infarct-related artery is performed by experienced operators, according to standard clinical practice, using standard material such as guide-wires, balloons and stents. Serial electrocardiograms (ECGs) are taken prior to, immediately after, 30 minutes, one hour, three and six hours after the final angiogram during the PCI-procedure. Continuous 12-lead ST-segment monitoring is started as early as possible and is continued for at least six hours after the procedure. The continuous ECG is recorded on a study device through routinely placed leads. The continuous ECGs are analysed at the eECG core lab at Duke Clinical Research Institute under the supervision of M. Krucoff.

Angiographic TIMI-graded coronary flow is documented prior to, and immediately after PCI, as well as myocardial blush grade and angiographic signs of distal branch embolisation on the final angiograms after completion of the procedure. Serial creatine kinase myocardial bands (CK-MB) mass, troponin-T, α-hydroxybutyrate dehydrogenase (α-HBDH) and n-terminal prohormone brain natriuretic peptide (NT proBNP) are measured for infarct-size estimation, according to standard clinical procedures.

Clinical follow-up is obtained at one and six months after randomisation and left ventricular function is assessed by magnetic resonance imaging (MRI) between six and nine months. Patients are studied on a clinical 1.5 or 3.0 Tesla scanner with a radio frequency receiver coil.

Functional imaging:
ECG-gated cine steady state free precession (SSFP) magnetic resonance (MR) images are obtained during repeated breath-holds in the three standard long axis views (four-, three- and two-chamber view). Additional short axis slices are acquired covering the entire left ventricle, to examine regional and global left ventricular function.

Infarct imaging:
During intravenous (i.v.) injection of gadopentetic acid (Gd-DTPA) first-pass perfusion imaging is performed with a saturation-recovery gradient-echo pulse sequence. Delayed contrast-enhanced images are acquired 10 and 30 minutes post-contrast with an inversion-recovery gradient-echo pulse sequence to identify the location and extent of myocardial infarction. The data are obtained with slice locations identical to the functional images.

In case of the use of the PROXIS™ combined embolic protection and thrombectomy device, the presence of evacuated material is evaluated by visual assessment and confirmed by pathology. During the study period, baseline data of all not-included patients undergoing primary PCI at our centre are documented.

Intervention type

Drug

Phase

Not Specified

Drug names

Acetylsalicylic acid, clopidogrel, abciximab and unfractionated heparin

Primary outcome measures

The primary endpoint of this study is a more than 70% resolution of ST-segment elevation at one hour after PCI, compared to ST-segment elevation immediately prior to PCI.

Secondary outcome measures

The secondary endpoints are:
1. ECG: the time course of the percentage of ST-segment elevation resolution (as a quantitative parameter)
2. Angiographic: the incidence of angiographic evidence distal embolisation based on TIMI-graded coronary flow, myocardial blush grade and distal branch occlusion
3. Laboratory: the myocardial infarct-size as assessed by serial CK-MB mass, troponin-T, α-HBDH, and NT proBNP, according to standard clinical practice
4. MRI: the difference of infarct size measured by left ventricular ejection fraction (LVEF) and by contrast enhanced MRI-infarct size between six and nine months after PCI, between patients treated by standard PCI and patients treated by PCI combined embolic protection and thrombectomy using the PROXIS™
5. Clinical: the incidence of death, MI or rehospitalisation for non-ST-segment elevation acute coronary syndrome (nSTE-ACS), repeat PCI of the infarct related artery, CABG and stroke at one, six and 12 months.

ECG-evaluation for ST-elevation resolution is performed blinded to the randomisation. The TIMI flow rate, the myocardial blush grade and the presence of distal embolisation is assessed on the final angiograms, made immediately following the primary coronary angioplasty, by two experienced investigators who are blinded to all other data.

Overall trial start date

05/12/2005

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Consecutive patients with an acute ST-segment elevation MI undergoing primary PCI:
1. Primary PCI within six hours after onset of symptoms of myocardial infarction
2. Electrocardiographic evidence of persistent ST-segment elevation of at least 0.1 mV in two or more contiguous leads at the time of randomisation
3. Proximal obstruction of infarct related coronary artery with TIMI zero to two flow with minimal diameter of 2.5 mm or more
4. The obstruction is amenable to the use of the PROXIS™ as judged by an experienced operator

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

280

Participant exclusion criteria

1. Younger than 18 years of age
2. Use of a thrombolytic agent within the previous 48 hours
3. Prior coronary artery bypass graft (CABG)
4. Contraindications to the use of a glycoprotein (GP) IIb/IIIa inhibitor
5. Co-existent condition associated with a limited life expectancy

Recruitment start date

05/12/2005

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Canada, Netherlands

Trial participating centre

Department of Cardiology
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

University of Amsterdam (UvA)
Meibergdreef 9
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gove/pubmed/19850252
2. 2010 results in http://www.ncbi.nlm.nih.gove/pubmed/19858136

Publication citations

Additional files

Editorial Notes