coumadin trial summary

Acute coronary syndrome

ACS (excluding AMI): 2 trials - ASPECT-2 (coumadin+asp vs asp) - ASPECT-2 (coumadin vs aspirin)

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Extracranial hemorrhage	no data
all cause death, non-fatal MI, thrombo-embolic stroke	0.57 [0.31 1.05]	p=1.00	0	661	1	ASPECT-2 (coumadin vs aspirin),
intracranial hemorrhage	1.03 [0.02 52.26]	p=1.00	0	661	1	ASPECT-2 (coumadin vs aspirin),
Major bleeding	1.03 [0.21 5.16]	p=1.00	0	661	1	ASPECT-2 (coumadin vs aspirin),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

coumadin vs control (on top of aspirin)

No demonstrated result

Endpoint	TE [95% CI]	p val	n	k	trials
Extracranial hemorrhage	2.02 [0.50 8.14]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),
all cause death, non-fatal MI, thrombo-embolic stroke	0.56 [0.31 1.01]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),
intracranial hemorrhage	3.03 [0.12 74.58]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),
Major bleeding	2.35 [0.60 9.18]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

See more clinical conditions

All ACS (including AMI): 2 trials - ASPECT-2 (coumadin+asp vs asp) - ASPECT-2 (coumadin vs aspirin)

coumadin vs aspirin

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Extracranial hemorrhage	no data
all cause death, non-fatal MI, thrombo-embolic stroke	0.57 [0.31 1.05]	p=1.00	0	661	1	ASPECT-2 (coumadin vs aspirin),
intracranial hemorrhage	1.03 [0.02 52.26]	p=1.00	0	661	1	ASPECT-2 (coumadin vs aspirin),
Major bleeding	1.03 [0.21 5.16]	p=1.00	0	661	1	ASPECT-2 (coumadin vs aspirin),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

coumadin vs control (on top of aspirin)

No demonstrated result

Endpoint	TE [95% CI]	p val	n	k	trials
Extracranial hemorrhage	2.02 [0.50 8.14]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),
all cause death, non-fatal MI, thrombo-embolic stroke	0.56 [0.31 1.01]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),
intracranial hemorrhage	3.03 [0.12 74.58]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),
Major bleeding	2.35 [0.60 9.18]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

All type of patients: 2 trials - ASPECT-2 (coumadin+asp vs asp) - ASPECT-2 (coumadin vs aspirin)

coumadin vs aspirin

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Extracranial hemorrhage	no data
all cause death, non-fatal MI, thrombo-embolic stroke	0.57 [0.31 1.05]	p=1.00	0	661	1	ASPECT-2 (coumadin vs aspirin),
intracranial hemorrhage	1.03 [0.02 52.26]	p=1.00	0	661	1	ASPECT-2 (coumadin vs aspirin),
Major bleeding	1.03 [0.21 5.16]	p=1.00	0	661	1	ASPECT-2 (coumadin vs aspirin),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

coumadin vs control (on top of aspirin)

No demonstrated result

Endpoint	TE [95% CI]	p val	n	k	trials
Extracranial hemorrhage	2.02 [0.50 8.14]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),
all cause death, non-fatal MI, thrombo-embolic stroke	0.56 [0.31 1.01]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),
intracranial hemorrhage	3.03 [0.12 74.58]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),
Major bleeding	2.35 [0.60 9.18]	p=1.00	669	1	ASPECT-2 (coumadin+asp vs asp),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Acute myocardial infarction

All type of patients: 3 trials - ASPECT-2 (coumadin alone) - ASPECT - ASPECT-2 (coumadin+ASA vs ASA)

coumadin vs aspirin

No demonstrated result

suggested All cause death by 72% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Extracranial hemorrhage	no data
all cause death, MI, thrombo-embolic stroke	0.57 [0.31 1.05]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),
myocardial infarction (fatal and non fatal)	0.96 [0.44 2.08]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),
stroke (fatal and non fatal)	no data
ischemic stroke	no data
Coronary event	no data
Coronary death	no data
Revascularization	0.90 [0.55 1.47]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),
All cause death	0.28 [0.09 0.84]	p=0.04	0	661	1	ASPECT-2 (coumadin alone),
Minor bleeding	1.68 [0.88 3.19]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),
intracranial hemorrhage	1.03 [0.02 52.26]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),
Major bleeding	1.03 [0.21 5.16]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

coumadin vs control (on top of aspirin)

No demonstrated result

suggested Minor bleeding by 203% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Extracranial hemorrhage	no data
all cause death, MI, thrombo-embolic stroke	no data
myocardial infarction (fatal and non fatal)	0.69 [0.30 1.59]	p=1.00	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),
stroke (fatal and non fatal)	no data
ischemic stroke	0.09 [0.00 1.60]	p=1.00	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),
Coronary event	no data
Coronary death	no data
Revascularization	0.80 [0.48 1.31]	p=1.00	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),
All cause death	0.58 [0.25 1.35]	p=1.00	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),
Minor bleeding	3.03 [1.68 5.46]	p=0.04	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),
intracranial hemorrhage	no data
Major bleeding	2.26 [0.58 8.84]	p=1.00	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

coumadin vs placebo

No demonstrated result

suggested myocardial infarction (fatal and non fatal) by 53% (not demonstrated)

suggested ischemic stroke by 40% (not demonstrated)

suggested Major bleeding by 285% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Extracranial hemorrhage	no data
all cause death, MI, thrombo-embolic stroke	no data
myocardial infarction (fatal and non fatal)	0.47 [0.37 0.60]	p=0.04	0	3404	1	ASPECT,
stroke (fatal and non fatal)	no data
ischemic stroke	0.60 [0.40 0.90]	p=0.04	0	3404	1	ASPECT,
Coronary event	no data
Coronary death	no data
Revascularization	no data
All cause death	0.90 [0.72 1.12]	p=1.00	0	3404	1	ASPECT,
Minor bleeding	no data
intracranial hemorrhage	no data
Major bleeding	3.85 [2.31 6.41]	p=0.04	0	3404	1	ASPECT,

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Atrial fibrillation

Primary prevention of thromboembolic events: 1 trials - PATAF (coumadin low dose vs coumadin standard dose)

coumadin low dose vs coumadin standard dose

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
systemic thrombo-embolic complication	no data
thrombo-embolic event (cerebral or systemic)	1.07 [0.21 5.42]	p=1.00	0	253	1	PATAF (coumadin low dose vs coumadin standard dose),
TE event or ischemic stroke or systemic embolism	1.07 [0.21 5.42]	p=1.00	0	253	1	PATAF (coumadin low dose vs coumadin standard dose),
ischemic stroke	1.61 [0.26 9.81]	p=1.00	0	253	1	PATAF (coumadin low dose vs coumadin standard dose),
Lifethreatening major bleeding	no data
Non-lifethreatening major bleeding	no data
Gastrointestinal major bleeding	no data
major or clinically relevant non-major bleeding	no data
hypertransaminasemia	no data
Major bleeding	no data
Haemmorhagic stroke	1.07 [0.07 17.36]	p=1.00	0	253	1	PATAF (coumadin low dose vs coumadin standard dose),
Fatal bleeding	no data
Cardiovascular death	0.48 [0.14 1.59]	p=1.00	0	253	1	PATAF (coumadin low dose vs coumadin standard dose),
stroke (fatal and non fatal)	1.43 [0.31 6.53]	p=1.00	0	253	1	PATAF (coumadin low dose vs coumadin standard dose),
Coronary event	no data
All cause death	0.72 [0.28 1.82]	p=1.00	0	253	1	PATAF (coumadin low dose vs coumadin standard dose),
Fatal stroke	5.37 [0.26 112.97]	p=1.00	0	253	1	PATAF (coumadin low dose vs coumadin standard dose),
Non fatal stroke	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Post myocardial infarction

All type of patients: 3 trials - ASPECT-2 (coumadin alone) - ASPECT - ASPECT-2 (coumadin+ASA vs ASA)

coumadin vs aspirin

No demonstrated result

suggested All cause death by 72% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Extracranial hemorrhage	no data
all cause death, MI, thrombo-embolic stroke	0.57 [0.31 1.05]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),
myocardial infarction (fatal and non fatal)	0.96 [0.44 2.08]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),
stroke (fatal and non fatal)	no data
ischemic stroke	no data
Coronary event	no data
Coronary death	no data
Revascularization	0.90 [0.55 1.47]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),
All cause death	0.28 [0.09 0.84]	p=0.04	0	661	1	ASPECT-2 (coumadin alone),
Minor bleeding	1.68 [0.88 3.19]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),
intracranial hemorrhage	1.03 [0.02 52.26]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),
Major bleeding	1.03 [0.21 5.16]	p=1.00	0	661	1	ASPECT-2 (coumadin alone),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

coumadin vs control (on top of aspirin)

No demonstrated result

suggested Minor bleeding by 203% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Extracranial hemorrhage	no data
all cause death, MI, thrombo-embolic stroke	no data
myocardial infarction (fatal and non fatal)	0.69 [0.30 1.59]	p=1.00	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),
stroke (fatal and non fatal)	no data
ischemic stroke	0.09 [0.00 1.60]	p=1.00	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),
Coronary event	no data
Coronary death	no data
Revascularization	0.80 [0.48 1.31]	p=1.00	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),
All cause death	0.58 [0.25 1.35]	p=1.00	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),
Minor bleeding	3.03 [1.68 5.46]	p=0.04	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),
intracranial hemorrhage	no data
Major bleeding	2.26 [0.58 8.84]	p=1.00	0	587	1	ASPECT-2 (coumadin+ASA vs ASA),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

coumadin vs placebo

No demonstrated result

suggested myocardial infarction (fatal and non fatal) by 53% (not demonstrated)

suggested ischemic stroke by 40% (not demonstrated)

suggested Major bleeding by 285% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Extracranial hemorrhage	no data
all cause death, MI, thrombo-embolic stroke	no data
myocardial infarction (fatal and non fatal)	0.47 [0.37 0.60]	p=0.04	0	3404	1	ASPECT,
stroke (fatal and non fatal)	no data
ischemic stroke	0.60 [0.40 0.90]	p=0.04	0	3404	1	ASPECT,
Coronary event	no data
Coronary death	no data
Revascularization	no data
All cause death	0.90 [0.72 1.12]	p=1.00	0	3404	1	ASPECT,
Minor bleeding	no data
intracranial hemorrhage	no data
Major bleeding	3.85 [2.31 6.41]	p=0.04	0	3404	1	ASPECT,

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Superficial thrombophlebitis

Superficial thrombophlebitis of the leg : 1 trials - Belcaro (coumadin vs low dose hep)

coumadin vs low dose heparin

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Deep vein thrombosis	no data
Venous thromboembolism end of treatment	no data
Venous thromboembolism	no data
Pain disappearance	no data
Major bleeding	no data
Extension and/or recurrence of SVT	no data
Heparin-induced thrombocytopenia	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Coumadin antithrombotics

Acute coronary syndrome

Acute myocardial infarction

Atrial fibrillation

Post myocardial infarction

Superficial thrombophlebitis