On-treatment PLAtelet Reactivity-guided Therapy Modification FOR ST-segment Elevation Myocardial Infarction

NCT01739556 | Terminated Phase 3 DMC

• 1 other identifier: CCS-553-12
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate platelet inhibition with dual antiplatelet therapy is a key therapeutic goal after primary percutaneous coronary intervention (PPCI), aimed at protecting against stent thrombosis and increased mortality. Recent aggregometric assays have shown that up to one third of acute coronary syndrome patients treated with clopidogrel have incomplete inhibition of adenosine diphosphate(ADP)-induced platelet aggregation while the number of patients treated with aspirin who have incomplete inhibition of thromboxane A2-induced platelet aggregation (ASPI)is much lower. High on-treatment platelet reactivity (HTPR) has been associated with an increased rate of ischemic events after PCI. However, recent large trials did not show a clinical benefit of TPR-guided therapy modification in acute coronary syndrome patients treated by PCI. On-treatment PLAtelet reactivity-guided Therapy modification FOR ST-segment elevation Myocardial infarction (PLATFORM) is an investigator-initiated, prospective, randomized, parallel-group, controlled clinical trial designed to test the hypothesis that antiplatelet therapy modification is superior to standard antiplatelet regimen among intermediate to high-risk STEMI patients undergoing PPCI. The safety hypothesis is that compared with control arm, interventional study arm will have similar rates of non-coronary artery bypass graft surgery-related bleeding. Approximately 632 ST-elevation myocardial infarction (STEMI) patients with intermediate to high-risk (RISK-PCI score \>3) clinical features undergoing PPCI will be randomly allocated to treatment modification or standard treatment. Low responders to aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel will receive 180 mg ticagrelor for 1 year. Patients will be followed up to 1 year after PPCI.

Conditions

Acute ST-elevation Myocardial Infarction

Keywords

antiplatelet therapy; primary PCI; modification

Outcome Measures

Primary Outcomes (1)

• MACE

  The PLATFORM specified primary efficacy end point is the time to first occurrence of any component of the composite MACE (comprising total death, nonfatal infarction, nonfatal stroke and immediate target vessel revascularization).

  up to 1 year

Secondary Outcomes (7)

• Total death

  up to 1 year

• Major bleeding

  up to 1 year

• Total bleeding

  up to 1 year

• Reinfarction

  up to 1 year

• Stroke

  up to 1 year

Other Outcomes (1)

• Stent thrombosis

  up to 1 year

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Antiplatelet regimen modification will be guided by assessment of the on-treatment platelet reactivity. Low responders to aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel will receive 180 mg ticagrelor for 1 year.

Drug: Antiplatelet Regimen Modification (aspirin or ticagrelor)

Standard Treatment

NO INTERVENTION

Patients enrolled in the Standard Treatment arm will receive standard antiplatelet regimen including 100 mg aspirin and 75 mg clopidogrel without assessment of on-treatment platelet reactivity.

Interventions

Antiplatelet Regimen Modification (aspirin or ticagrelor) DRUG

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older, willing consent, undergoing primary PCI for STEMI, within 12 hours of the onset of symptoms, stent implanted successfully, RISK-PCI score for 30-day MACE \>3, alive 24 hours after loading doses, ability to comply with study protocol, negative pregnancy test for women of childbearing potential before enrollment, agree to use a reliable method of birth control during the study

You may not qualify if:

• Pre-procedural
• history of hemorrhagic stroke
• ischemic stroke within 30 days of randomization
• evidence of active abnormal bleeding within 3 months of randomization
• high risk for bleeding on long-term antiplatelet therapy
• current therapy with coumadin anticoagulant
• Pregnancy or nursing
• current enrollment in another investigational study Procedural
• balloon angioplasty without stent placement
• unsuccessful PPCI (post-procedural TIMI flow 0) Post-procedural
• active bleeding
• hemoglobin \<10 g/dL or drop in hemoglobin by ≥3 g/dL
• platelet count \<100 000 x 10-9/L.
• TRAP value \<500 aggregation units
• indication for permanent anticoagulant therapy

Sponsors & Collaborators

• Clinical Centre of Serbia: lead

Study Sites (1)

Clinical Centre of Serbia, Emergency Hospital

Belgrade, 11000, Serbia

Location

Related Publications (1)

• 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 Jun;26(3):221-7. doi: 10.1111/j.1540-8183.2013.12024.x. Epub 2013 Feb 4.

  PMID: 23373620 DERIVED

MeSH Terms

Interventions

Aspirin; Ticagrelor

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Igor Mrdovic, Ph.D

  Clinical Centre of Sebria

  PRINCIPAL INVESTIGATOR

• Jovan Perunicic, Ph.D

  Clinical Centre of Serbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: December 3, 2012
• Study Start: June 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2017-02

Locations

SE (1)