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July 14, 2020TrialsOpen Access

Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design

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Key result

Periprocedural acetylsalicylic acid and unfractionated heparin are being evaluated for their effect on 90-day functional outcome in patients undergoing endovascular treatment for acute ischemic stroke.

Why the study?

It is unknown whether periprocedural antithrombotic medication with acetylsalicylic acid or unfractionated heparin improves functional outcome in patients undergoing endovascular treatment for acute ischemic stroke.

Does periprocedural acetylsalicylic acid and/or unfractionated heparin improve functional outcome in adult patients with acute ischemic stroke undergoing endovascular treatment?

Population

1500 planned adult patients undergoing EVT for anterior circulation large vessel occlusion stroke

Comparison

Intravenous ASA (300 mg), UFH (low or moderate dose), both, or neither

Design

Multicenter phase III prospective 2 × 3 factorial open-label blinded end-point randomized trial

Follow-up

90 days

Authors

VCVicky ChalosErasmus MCRGRob A. van de GraafErasmus MCBRBob RoozenbeekDefense Information Systems Agency

Discussion

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Implication

The MR CLEAN-MED trial is designed to evaluate whether adjunctive periprocedural antithrombotic medication (ASA and/or UFH) improves functional outcomes in patients undergoing endovascular treatment for acute ischemic stroke.

Study Design

Type

RCT (n=1,500)

Blinding

Open-label, blinded end-point (PROBE)

Randomization

2x3 factorial

Multicenter

Yes

Structured PICO

Does periprocedural acetylsalicylic acid and/or unfractionated heparin improve functional outcome in adult patients with acute ischemic stroke undergoing endovascular treatment?

P
Population
A planned 1,500 adult patients with acute ischemic stroke and confirmed anterior circulation large vessel occlusion eligible for endovascular treatment within 6 hours of symptom onset, followed for 90 days.
I
Intervention
Intravenous acetylsalicylic acid (300 mg) and/or unfractionated heparin (low or moderate dose) as adjunctive therapy to endovascular treatment (EVT).
C
Comparator
Neither acetylsalicylic acid nor unfractionated heparin as adjunctive therapy to endovascular treatment (EVT).
O
Outcome
Score on the modified Rankin Scale (mRS) at 90 days.hard clinical

The MR CLEAN-MED trial is designed to evaluate whether adjunctive periprocedural antithrombotic medication (ASA and/or UFH) improves functional outcomes in patients undergoing endovascular treatment for acute ischemic stroke.

Limitations

  • Open label design may introduce bias
  • Deferred consent procedure may lead to underestimation of true safety if patients with severe adverse events refuse consent
  • Assumption of independence in mechanisms of action between study treatments

Cite This Study

Chalos et al. (2020) conducted an RCT in Acute ischemic stroke (n=1,500). Acetylsalicylic acid (ASA) and/or unfractionated heparin (UFH) vs. No ASA and no UFH was evaluated on Modified Rankin Scale (mRS) score at 90 days. Periprocedural acetylsalicylic acid and unfractionated heparin are being evaluated for their effect on 90-day functional outcome in patients undergoing endovascular treatment for acute ischemic stroke.

synapsesocial.com/papers/6a9a76d0861e0cddfb4e2049https://doi.org/10.1186/s13063-020-04514-9
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