Condition category
Circulatory System
Date applied
23/03/2012
Date assigned
22/05/2012
Last edited
30/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Prof Igor Mrdovic

ORCID ID

Contact details

Clinical Center of Serbia
Pasterova 2
Belgrade
11000
Serbia
+38 11 1366 2364
igormrd@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

553/12

Study information

Scientific title

Post-treatment PLATelet aggregation-guided therapy FOR ST-segment elevation Myocardial infarction: a randomized trial

Acronym

PLATFORM

Study hypothesis

Antiplatelet regimen tailoring is superior to standard antiplatelet regimen in intermediate to high-risk ST-segment elevation myocardial infarction (STEMI) patients treated with primary percutaneous coronary intervention (PCI), with regard to the primary end point.

Ethics approval

Ethics Committee, Clinical Center of Serbia, 02/06/2009, ref: 553/12

Study design

Prospective open-label observer-blinded randomized parallel-group actively controlled single-center clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute myocardial infaction with ST elevation

Intervention

Before pPCI, 300 mg aspirin and 600 mg clopidogrel loading doses will be administered. Unfractionated heparin is started as 100 IU/kg bolus (60 IU/kg if glycoprotein (GP) IIb/IIIa receptor inhibitor was used); the 12 IU/kg/h infusion followed if clinically indicated (atrial fibrillation, left ventricular (LV) thrombus or aneurysm, recent or recurrent venous thromboembolism, deferred sheath removal). Proton-pump inhibitor pantoprazole or H2-blocker ranitidine will be given to selected patients at risk for gastrointestinal hemorrhage. GP IIb/IIIa receptor inhibitor tirofiban will be administered during the procedure at the discretion of the operator.

Patients will be randomly allocated to ART (interventional arm) or standard treatment (control arm) using a computer-generated 1:1 simple randomization scheme. Post-treatment platelet aggregation (PPA) will be assessed in patients enrolled in the intervention arm of the trial. Patients enrolled in the control arm will receive standard antiplatelet regimen including 100 mg aspirin and 75 mg clopidogrel without assessment of PPA. The treating physicians will not be blinded to the intervention since an open design will make it possible for investigators to perform necessary adjustments of the antiplatelet regimen in accordance with PPA status. To minimize any possible bias inherent in the open design, endpoints will be evaluated by a blinded endpoint committee (Probe design). This will limit investigator bias and allow for a valid analysis despite the open design.

ASPI and ADP tests will be used to analyze the effect of aspirin, clopidogrel and ticagrelor on PPA in the interventional arm. PPA above 50%, compared to the basal value estimated by thrombin-receptor agonist peptide (TRAP) test, will be linked with low responsiveness. Low responders to aspirin will receive 200 mg aspirin daily for 30 days. Low responders to clopidogrel will receive 180 mg ticagrelor daily for 1 year.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The time to the first of composite events including death, nonfatal infarction, stroke or definite subacute stent thrombosis. Major safety end points includeTIMI major bleeding unrelated to coronary artery bypass graft surgery. Patients will be followed-up after discharge from hospital at 30 days and 1 year after enrolment.

Secondary outcome measures

1. Individual components of MACE
2. Total bleeding and the need for blood transfusions

Patients will be followed-up after discharge from hospital at 30 days and 1 year after enrolment.

Overall trial start date

01/06/2012

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with intermediate to high risk for 30-day Major Adverse Cardiac Events (MACE) (RISK-PCI score >3) undergoing primary PCI with stent implantation within 12 hours of the onset of symptoms
2. Ability to comply with study protocol
3. Negative test for pregnancy for women of childbearing potential before enrollment and agreement to use a reliable method of birth control during the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

632

Participant exclusion criteria

Pre-procedural:
1. Any history of hemorrhagic stroke
2. Ischemic stroke within 30 days of randomization
3. Evidence of active abnormal bleeding within 3 months of randomization
4. High risk for bleeding on long-term clopidogrel therapy
5. Current therapy with coumadin anticoagulation
6. Pregnancy or nursing
7. Current enrollment in another investigational drug or device study

Procedural:
1. Balloon angioplasty without stent placement
2. Unsuccessful pPCI (post-procedural TIMI flow 0)

Post-procedural:
1. Died within 24 hours after loading dose
2. Active internal bleeding
3. Hemoglobin < 10 g/dL or drop in hemoglobin by ≥3 g/dL
4. Platelet count < 100 000 x 10-9/L.
5. Thrombin Receptor Activating Peptide (TRAP) value <500 AU
6. Indication for permanent anticoagulant therapy

Recruitment start date

01/06/2012

Recruitment end date

01/06/2014

Locations

Countries of recruitment

Serbia

Trial participating centre

Clinical Center of Serbia
Belgrade
11000
Serbia

Sponsor information

Organisation

Clinical Center of Serbia (Serbia)

Sponsor details

Pasterova 2
Belgrade
11000
Serbia
+38 11 1361 7777
mediacentar@klinicki-centar.co.rs

Sponsor type

Hospital/treatment centre

Website

http://www.ksc.ac.rs

Funders

Funder type

Hospital/treatment centre

Funder name

Clinical Center of Serbia (Serbia)

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23373620

Publication citations

  1. Protocol

    Mrdovic I, Savic L, Krljanac G, Asanin M, Cvetinovic N, Brdar N, Stojanovic M, Djuricic N, Stankovic S, Marinkovic J, Perunicic J, Rationale and design of the on-treatment PLAtelet Reactivity-Guided Therapy Modification FOR ST-Segment Elevation Myocardial Infarction (PLATFORM) randomized trial., J Interv Cardiol, 2013, 26, 3, 221-227, doi: 10.1111/j.1540-8183.2013.12024.x.

Additional files

Editorial Notes