What question did this study set out to answer?

To evaluate the efficacy and clinical impact of a 150 mg clopidogrel maintenance dose in stable angina patients exhibiting high on-clopidogrel platelet reactivity identified via light transmission aggregometry.

September 9, 2011European Journal of Clinical Investigation

Justification of 150 mg clopidogrel in patients with high on‐clopidogrel platelet reactivity

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Why the study?

Does a 150 mg maintenance dose of clopidogrel reduce platelet reactivity and thrombo-ischaemic complications in stable angina patients with high on-clopidogrel platelet reactivity undergoing PCI?

Population

200 clopidogrel-naive stable angina patients before ad hoc percutaneous coronary intervention with high…

Comparison

Clopidogrel 150 mg maintenance dose for 4 weeks… vs Clopidogrel 75 mg maintenance dose for 4 weeks…

Design

RCT, randomly allocated, double-blind, placebo-controlled

Follow-up

1 year

Authors

DADániel AradiInterventional Cardiology OROrsolya RidegUniversity of Pecs AVAndrás VorobcsukInterventional / Structural Cardiology

Discussion

Member takes

Implication

Supports 150 mg clopidogrel maintenance in high-reactivity PCI patients; extends randomized evidence from platelet reactivity to 1-year ischemic outcomes.

Key Points

To evaluate the efficacy and clinical impact of a 150 mg clopidogrel maintenance dose in stable angina patients exhibiting high on-clopidogrel platelet reactivity identified via light transmission aggregometry.
Randomized, double-blind, placebo-controlled trial (NCT00638326) in clopidogrel-naive stable angina patients undergoing ad hoc percutaneous coronary intervention, prematurely terminated at N=200.
Patients identified with high on-treatment platelet reactivity (maximal aggregation ≥34% using 5 μM ADP) 12–24 hours post-600 mg loading dose were randomized to 75 mg or 150 mg daily clopidogrel for 4 weeks.
Platelet aggregation and vasodilator-stimulated phosphoprotein phosphorylation were measured at day 28, followed by 75 mg clopidogrel maintenance for all patients through 1-year follow-up.
At day 28, 150 mg clopidogrel significantly reduced maximal aggregation (45.0 ± 6.8 vs. 33.8 ± 15.1, P < 0.01), late aggregation (27.1 ± 14.7 vs. 13.8 ± 18.0, P < 0.01), and VASP-PRI (57.5 ± 15.2 vs. 37.2 ± 17.1, P < 0.01), whereas reactivity was unchanged with 75 mg.
The 150 mg regimen significantly reduced 1-year incidence of cardiovascular death and myocardial infarction compared to 75 mg (0% vs. 11.4%, P = 0.04).
The 1-year composite endpoint of cardiovascular death, myocardial infarction, or target vessel revascularization was significantly lower in the 150 mg group than the 75 mg group (3.1% vs. 24.6%, P = 0.01).

Structured PICO

Does a 150 mg maintenance dose of clopidogrel reduce platelet reactivity and thrombo-ischaemic complications in stable angina patients with high on-clopidogrel platelet reactivity undergoing PCI?

Population

200 clopidogrel-naive stable angina patients before ad hoc percutaneous coronary intervention with high on-clopidogrel platelet reactivity (HPR) identified with conventional aggregometry (AGGmax ≥ 34%) after a 600-mg loading dose.

Intervention

Clopidogrel 150 mg maintenance dose for 4 weeks, followed by 75 mg until 1 year.

Comparator

Clopidogrel 75 mg maintenance dose for 4 weeks, followed by 75 mg until 1 year.

Outcome

Platelet aggregation (AGGmax, AGGlate) and vasodilator-stimulated phosphoprotein phosphorylation (VASP-PRI) at day 28.surrogate

A 1-month maintenance dose of 150 mg clopidogrel reduces platelet reactivity and the risk of thrombo-ischemic complications in stable angina patients with high on-treatment platelet reactivity identified by light transmittance aggregometry.

Limitations

Prematurely terminated at the stage of 200 enrolled patients

Cite This Study

Aradi et al. (2011) studied this question.

synapsesocial.com/papers/6a1df12ccd67cee373350bc4 https://doi.org/10.1111/j.1365-2362.2011.02594.x

Topics

Dual antiplatelet therapy

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Implication

Supports 150 mg clopidogrel maintenance in high-reactivity PCI patients; extends randomized evidence from platelet reactivity to 1-year ischemic outcomes.

Justification of 150 mg clopidogrel in patients with high on‐clopidogrel platelet reactivity

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Topics

Justification of 150 mg clopidogrel in patients with high on‐clopidogrel platelet reactivity

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Also Consider

Topics

Also Consider