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TEACH

Trial of Enoxaparin vs Aspirin in Patients With Cancer and Stroke

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Year of Publication: 2018

Authors: Babak B. Navi, Randolph S. Marshall, Dylan Bobrow, ..., Lisa M. DeAngelis

Journal: JAMA Neurology

Citation: JAMA Neurol. 2018;75(3):379-381

Link: https://jamanetwork.com/journals/jamaneu...article/2668461

Clinical Question

What is the optimal antithrombotic strategy (anticoagulation vs antiplatelet therapy) for patients with active cancer and acute ischemic stroke?

Bottom Line

This pilot study demonstrated feasibility for enrolling cancer patients with stroke but was underpowered to determine optimal antithrombotic therapy; high crossover rates from enoxaparin to aspirin due to injection aversion suggest future trials should consider oral anticoagulants.

        Major Points
        First randomized trial comparing anticoagulation vs antiplatelet therapy in cancer patients with acute ischemic stroke
Pilot study enrolled 20 of 49 eligible patients (41% enrollment rate), meeting prespecified feasibility endpoint of >30%
Leading exclusion criteria were clear indications for anticoagulation (30%) and inactive cancer (20%)
60% of patients randomized to enoxaparin crossed over to aspirin due to discomfort with injections or drug costs
No significant differences in bleeding, thromboembolic events, or survival between groups

      

Design

Study Type: Pilot, open-label, randomized controlled trial

Randomization: 1

Blinding: Open-label (no blinding)

Enrollment Period: January 2013 to April 2016

Follow-up Duration: 12 months

Centers: 3

Countries: United States

Sample Size: 20

Analysis: Intention-to-treat; descriptive statistics and Kaplan-Meier survival analyses

Inclusion Criteria

Age 18 to 85 years
Active solid or hematological cancer
MRI-confirmed acute ischemic stroke within 4 weeks
Stroke mechanisms adjudicated after standardized evaluations

Exclusion Criteria

Clear indications for anticoagulation
No active cancer
Unable to get MRI or no stroke on MRI results
Life expectancy <1 month or hospice
Primary brain tumor
Intracranial hemorrhage within 3 months
Platelet count ≤70 × 10³/μL
Hemoglobin level <8 g/dL
High-risk bleeding condition/diathesis
Active/serious bleeding within 2 weeks
Clear indication for antiplatelet therapy
Symptomatic ICA stenosis
INR >1.6 or PTT >40 s
AST or ALT level >200 U/L
Serum creatinine level >2 mg/dL
Aspirin allergy

Arms

Field	Enoxaparin	Control
Intervention	Subcutaneous enoxaparin 1 mg/kg twice daily for 6 months	Oral aspirin 81-325 mg daily for 6 months
Duration	6 months	6 months

Outcomes

Outcome	Type	Control	Intervention
Feasibility defined as enrollment rate among 100 eligible patients with lower-bound 95% CI exceeding 30%	Primary
Enrollment rate achieved	Secondary		41% (20 of 49 eligible patients)
Crossover from enoxaparin to aspirin	Secondary	0%	60% (6/10 patients)
Nonfatal gastrointestinal bleeding	Adverse	3 patients	0 patients
Nonfatal pulmonary hemorrhage	Adverse	0 patients	1 patient
Nonfatal myocardial infarction	Adverse	1 patient	0 patients
Fatal recurrent AIS	Adverse	0 patients	1 patient

Subgroup Analysis

No subgroup analyses performed due to small sample size

Criticisms

Very small sample size (n=20) limits power for efficacy and safety conclusions
High crossover rate (60%) from enoxaparin to aspirin compromises intention-to-treat analysis
Open-label design introduces potential bias
Study terminated early due to funding constraints before reaching target enrollment
Single-center recruitment from specialized cancer and stroke centers may limit generalizability
Short follow-up period may miss late outcomes

Funding

National Institutes of Health grants KL2TR000458-06, K23NS091395, P30CA008748, and Florence Gould Endowment for Discovery in Stroke

Based on: TEACH (JAMA Neurology, 2018)

Authors: Babak B. Navi, Randolph S. Marshall, Dylan Bobrow, ..., Lisa M. DeAngelis

Citation: JAMA Neurol. 2018;75(3):379-381

Content summarized and formatted by NeuroTrials.ai.

TEACH

(2018)

Objective

To compare enoxaparin versus aspirin in patients with active cancer and acute ischemic stroke

Study Summary

• No significant differences in major bleeding, thromboembolic events, or survival between aspirin and enoxaparin for cerebral venous thrombosis
• Trial halted early due to slow enrollment (20 of 49 eligible enrolled)
• 60% of enoxaparin patients crossed over to aspirin

Intervention

Open-label randomized trial comparing subcutaneous enoxaparin (1 mg/kg twice daily) versus oral aspirin (81-325 mg daily) for 6 months in cancer patients with acute ischemic stroke

Inclusion Criteria

Age 18-85 years, active solid or hematologic cancer, MRI-confirmed acute ischemic stroke within 4 weeks

Study Design

Arms: Enoxaparin (1 mg/kg subcutaneous twice daily) vs Aspirin (81-325 mg oral daily)

Patients per Arm: 10 per arm

Outcome

• 3 aspirin patients had nonfatal GI bleeding, 1 enoxaparin patient had nonfatal pulmonary hemorrhage
• 1 aspirin patient had nonfatal MI, 1 enoxaparin patient had fatal recurrent stroke
• No significant differences in major bleeding, thromboembolic events, or survival

Bottom Line

Major Points

First randomized trial comparing anticoagulation vs antiplatelet therapy in cancer patients with acute ischemic stroke
Pilot study enrolled 20 of 49 eligible patients (41% enrollment rate), meeting prespecified feasibility endpoint of >30%
Leading exclusion criteria were clear indications for anticoagulation (30%) and inactive cancer (20%)
60% of patients randomized to enoxaparin crossed over to aspirin due to discomfort with injections or drug costs
No significant differences in bleeding, thromboembolic events, or survival between groups

Study Design

Study Type: Pilot, open-label, randomized controlled trial
Randomization: Yes
Blinding: Open-label (no blinding)
Sample Size: 20
Follow-up: 12 months
Centers: 3
Countries: United States

Primary Outcome

Definition: Feasibility defined as enrollment rate among 100 eligible patients with lower-bound 95% CI exceeding 30%

Control	Intervention	HR/OR	P-value
		- (27%-55%)

Limitations & Criticisms

Very small sample size (n=20) limits power for efficacy and safety conclusions
High crossover rate (60%) from enoxaparin to aspirin compromises intention-to-treat analysis
Open-label design introduces potential bias
Study terminated early due to funding constraints before reaching target enrollment
Single-center recruitment from specialized cancer and stroke centers may limit generalizability
Short follow-up period may miss late outcomes

Citation

JAMA Neurol. 2018;75(3):379-381

View Original Publication →

TEACH

Trial of Enoxaparin vs Aspirin in Patients With Cancer and Stroke

Clinical Question

Bottom Line

Major Points

Design

Inclusion Criteria

Exclusion Criteria

Arms

Outcomes

Subgroup Analysis

Criticisms

Funding

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