Antiplatelet therapy tailoring after primary percutaneous coronary intervention (PCI)

Antiplatelet Regimen Tailoring after primary Percutaneous Coronary Intervention (ART-PCI): a single centre longitudinal cohort prospective trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN64082539

Enrollment

1700

Registered

2010-02-18

Start date

2008-06-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

ST-elevation myocardial infarction (STEMI) Circulatory System Subsequent myocardial infarction

Interventions

Multiple electrode aggregometry (MEA) is performed using an impedance aggregometer (Multiplate analyzer, Dynabyte GmbH, Munich, Germany). Whole blood is sampled 24 hours after the procedure and placed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. ST-elevation myocardial infection (STEMI) patients undergoing primary PCI in our institution 2. Both genders, aged greater than 18 years 3. Platelet residual aggregation (PRA) assessed 24 hours after the loading with clopidogrel 600 mg 4. Control group: 1000 patients enrolled in the RISK-PCI trial (see http://www.controlled-trials.com/ISRCTN83474650) in our centre from February 1st, 2006 till June 1st, 2008, who did not have platelet function assays Low responders to clopidogrel will be subjected to ART if there is no exclusion criteria for ART.

Exclusion criteria

Exclusion criteria: 1. Not alive until 24 hours from clopidogrel loading 600 mg 2. Aged greater than 75 years 3. Percutaneous balloon angioplasty (POBA) without stenting 4. Failed pPCI 5. Active bleeding in hospital 6. Coronary dissection with pericardial collection 7. Haemoglobin (Hb) less than 80 g/dL needing transfusion in hospital 8. Simultaneous treatment with oral anticoagulants 9. Candidates for urgent bypass surgery 10. Low basal thrombin receptor activating peptide (TRAP) value (less than 500 AU/minute) 11. Hystory of recent bleeding from ulcer 12. Thrombocyte count less than 100,000/ml 13. Drug non-compliance 14. Withdrawal of consent

Design outcomes

Primary

Measure	Time frame
Efficacy outcome: Major adverse cardiovascular events (MACE). MACE comprises death, nonfatal reinfarction, ischaemic stroke and target vessel revascularisation (TVR). Nonfatal reinfarction is defined as the presence of at least two of the three following criteria: 1. Recurrent ischaemic chest pain longer than 20 minutes 2. Reoccurrence of ST elevation greater than 0.1 mV or new pathognomonic Q waves in at least two contiguous leads, and 3. Increase of cardiac troponin over the upper reference limit (URL) and over 50% of the lowest recovery level from the index myocardial infaction (MI) The more than triple URL value of cardiac troponin after PCI is defined as PCI-related myocardial infarction. Stroke is defined as a new onset of focal or global neurological deficit lasting more than 24 hours, and is computed tomography (CT)-classified as ischaemic. Haemorrhagic stroke is counted as life-threatening bleeding and is not included into stroke analyses. Target-vessel revascularisation is defined as ischaemia-driven revascularisation of the infarction-related artery during the follow-up period. Safety outcome: Major bleeding. Bleeding events were classified according to Thrombolysis In Myocardial Infarction (TIMI) criteria. All primary and secondary endpoints will be recorded at 1 month and at 1 year after the enrolment.	—

Measure

Time frame

Efficacy outcome: Major adverse cardiovascular events (MACE). MACE comprises death, nonfatal reinfarction, ischaemic stroke and target vessel revascularisation (TVR). Nonfatal reinfarction is defined as the presence of at least two of the three following criteria: 1. Recurrent ischaemic chest pain longer than 20 minutes 2. Reoccurrence of ST elevation greater than 0.1 mV or new pathognomonic Q waves in at least two contiguous leads, and 3. Increase of cardiac troponin over the upper reference limit (URL) and over 50% of the lowest recovery level from the index myocardial infaction (MI) The more than triple URL value of cardiac troponin after PCI is defined as PCI-related myocardial infarction. Stroke is defined as a new onset of focal or global neurological deficit lasting more than 24 hours, and is computed tomography (CT)-classified as ischaemic. Haemorrhagic stroke is counted as life-threatening bleeding and is not included into stroke analyses. Target-vessel revascularisation is defined as ischaemia-driven revascularisation of the infarction-related artery during the follow-up period. Safety outcome: Major bleeding. Bleeding events were classified according to Thrombolysis In Myocardial Infarction (TIMI) criteria. All primary and secondary endpoints will be recorded at 1 month and at 1 year after the enrolment.

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Secondary

Measure	Time frame
Subacute stent thrombosis. All primary and secondary endpoints will be recorded at 1 month and at 1 year after the enrolment.	—

Countries

Serbia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026