Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT03907046

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Led by Yale University · Updated on 2026-05-08

700

Participants Needed

187

Research Sites

374 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.

CONDITIONS

Official Title

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at least 18 years
  • Intracerebral hemorrhage (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
  • Can be randomized within 14 to 180 days after ICH onset
  • Non-valvular atrial fibrillation or atrial flutter documented by electrocardiography or physician-confirmed history
  • Signed and dated informed consent form by patient or legally authorized representative
  • For females of reproductive potential: use of highly effective contraception
Not Eligible

You will not qualify if you...

  • Hemorrhagic transformation of a brain infarction or hemorrhage into a tumor as index event
  • History of ICH within 12 months before the index event
  • Active infective endocarditis
  • Clear indication for anticoagulant or antiplatelet drugs for other conditions
  • Previous or planned left atrial appendage closure
  • Clinically significant bleeding disorder
  • Serum creatinine 2.5 mg/dL or higher
  • Active hepatitis or hepatic insufficiency with Child-Pugh score B or C
  • Chronic anemia (hemoglobin less than 8 g/dL) or thrombocytopenia (less than 100 x 10^9/L)
  • Pregnant or breastfeeding
  • Known allergy to aspirin or apixaban
  • Participation in another competing trial
  • Condition that precludes safe or active participation as judged by investigator
  • Persistent, uncontrolled systolic blood pressure 180 mm Hg or higher
  • ICH caused by unsecured arteriovenous malformation (AVM)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 187 locations

1

University of Alabama Hospital

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

University of South Alabama University Hospital

Mobile, Alabama, United States, 36604

Actively Recruiting

3

Chandler Regional Medical Center

Chandler, Arizona, United States, 85224

Withdrawn

4

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States, 85013

Withdrawn

5

Banner University Medical Center

Tucson, Arizona, United States, 85719

Actively Recruiting

6

UAMS Medical Center

Little Rock, Arkansas, United States, 77205

Withdrawn

7

Mercy San Juan Medical Center

Carmichael, California, United States, 95608

Actively Recruiting

8

Eden Medical Center, Castro Valley

Castro Valley, California, United States, 94546

Withdrawn

9

Arrowhead Regional Medical Center

Colton, California, United States, 92324

Actively Recruiting

10

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States, 90242

Suspended

11

Kaiser Permanente Fontana Medical Center

Fontana, California, United States, 92335

Actively Recruiting

12

Community Regional Medical Center of Fresno

Fresno, California, United States, 93720

Actively Recruiting

13

St. Jude Medical Center

Fullerton, California, United States, 92835

Actively Recruiting

14

Long Beach Memorial Medical Center

Long Beach, California, United States, 90806

Withdrawn

15

Los Alamitos Medical Center

Los Alamitos, California, United States, 90720

Actively Recruiting

16

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States, 90027

Actively Recruiting

17

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

18

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

19

Doctors Medical Center Modesto, Modesto, CA

Modesto, California, United States, 95350

Actively Recruiting

20

Hoag Hospital Newport Beach

Newport Beach, California, United States, 92663

Withdrawn

21

UC Irvine Medical Center

Orange, California, United States, 92868

Actively Recruiting

22

Desert Regional Medical Center

Palm Springs, California, United States, 92262

Actively Recruiting

23

Huntington Memorial Hospital

Pasadena, California, United States, 91105

Withdrawn

24

Kaiser Permanente Redwood City Medical Center, Redwood City, CA

Redwood City, California, United States, 94063

Actively Recruiting

25

UC Davis Medical Center

Sacramento, California, United States, 95817

Actively Recruiting

26

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States, 95825

Actively Recruiting

27

San Francisco General Hospital

San Francisco, California, United States, 94110

Actively Recruiting

28

Santa Barbara Cottage Hospital

Santa Barbara, California, United States, 93105

Actively Recruiting

29

Stanford University Medical Center

Stanford, California, United States, 94304

Actively Recruiting

30

PIH Health Hospital - Whittier

Whittier, California, United States, 90602

Actively Recruiting

31

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Actively Recruiting

32

St. Mary's Medical Center

Grand Junction, Colorado, United States, 81501

Withdrawn

33

Danbury Hospital

Danbury, Connecticut, United States, 06810

Suspended

34

Hartford Hospital

Hartford, Connecticut, United States, 06102

Actively Recruiting

35

Yale New Haven Hospital

New Haven, Connecticut, United States, 06511

Actively Recruiting

36

New Hanover Regional Medical Center

Wilmington, Delaware, United States, 28403

Actively Recruiting

37

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

38

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Withdrawn

39

George Washington University Hospital

Washington D.C., District of Columbia, United States, 20037

Actively Recruiting

40

Morton Plant Hospital

Clearwater, Florida, United States, 33756

Actively Recruiting

41

Broward Health Medical Center

Fort Lauderdale, Florida, United States, 33316

Actively Recruiting

42

UF Health Jacksonville

Jacksonville, Florida, United States, 32209

Actively Recruiting

43

Mayo Clinic

Jacksonville, Florida, United States, 32224

Terminated

44

Jackson Memorial Hospital

Miami, Florida, United States, 33136

Actively Recruiting

45

Ascension Sacred Heart Pensacola

Pensacola, Florida, United States, 32504

Actively Recruiting

46

Cleveland Clinic Tradition Hospital

Port Saint Lucie, Florida, United States, 34987

Actively Recruiting

47

Tampa General Hospital

Tampa, Florida, United States, 33606

Actively Recruiting

48

St. Joseph's Hospital

Tampa, Florida, United States, 33607

Actively Recruiting

49

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303

Actively Recruiting

50

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

51

Augusta University Medical Center

Augusta, Georgia, United States, 30912

Actively Recruiting

52

WellStar Kennestone Hospital

Marietta, Georgia, United States, 30060

Actively Recruiting

53

The Queen's Medical Center

Honolulu, Hawaii, United States, 96813

Actively Recruiting

54

Saint Alphonsus Regional Medical Center - Boise

Boise, Idaho, United States, 83706

Actively Recruiting

55

NCH Hospital, Arlington Heights

Arlington Heights, Illinois, United States, 60005

Actively Recruiting

56

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

57

University of Illinois Hospital

Chicago, Illinois, United States, 60612

Actively Recruiting

58

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

59

Evanston Hospital

Evanston, Illinois, United States, 60201

Actively Recruiting

60

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Actively Recruiting

61

OSF St. Francis Medical Center

Peoria, Illinois, United States, 61637

Actively Recruiting

62

Javon Bea Hospital - Riverside

Rockford, Illinois, United States, 61114

Withdrawn

63

St. John's Hospital

Springfield, Illinois, United States, 62769

Withdrawn

64

Central DuPage Hospital

Winfield, Illinois, United States, 60190

Actively Recruiting

65

IU Health Methodist Hospital

Indianapolis, Indiana, United States, 46202

Actively Recruiting

66

University of Iowa Medical Center

Iowa City, Iowa, United States, 52242

Actively Recruiting

67

University of Kansas Hospital

Kansas City, Kansas, United States, 66160

Actively Recruiting

68

Baptist Health Lexington

Lexington, Kentucky, United States, 40503

Actively Recruiting

69

University of Kentucky Hospital

Lexington, Kentucky, United States, 40536

Actively Recruiting

70

University of Louisville Hospital

Louisville, Kentucky, United States, 40202

Actively Recruiting

71

Ochsner Medical Center - Main Campus

New Orleans, Louisiana, United States, 70121

Actively Recruiting

72

Eastern Maine Medical Center

Bangor, Maine, United States, 04401

Withdrawn

73

Maine Medical Center

Portland, Maine, United States, 04102

Actively Recruiting

74

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

75

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

76

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

77

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

78

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States, 01805

Actively Recruiting

79

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Actively Recruiting

80

UMass Memorial Medical Center

Worcester, Massachusetts, United States, 01655

Actively Recruiting

81

University of Michigan University Hospital

Ann Arbor, Michigan, United States, 48109

Withdrawn

82

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Withdrawn

83

McLaren Flint

Flint, Michigan, United States, 48532

Withdrawn

84

Trinity Health Saint Mary's

Grand Rapids, Michigan, United States, 49503

Withdrawn

85

Trinity Health Saint Mary's

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

86

McLaren Macomb

Mount Clemens, Michigan, United States, 48043

Terminated

87

Munson Medical Center

Traverse City, Michigan, United States, 49684

Actively Recruiting

88

Metro Health Hospital

Wyoming, Michigan, United States, 49519

Withdrawn

89

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

90

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

91

St. Cloud Hospital

Saint Cloud, Minnesota, United States, 56303

Actively Recruiting

92

HealthPartners Methodist Hospital

Saint Louis Park, Minnesota, United States, 55426

Active, Not Recruiting

93

Regions Hospital

Saint Paul, Minnesota, United States, 55101

Terminated

94

United Hospital, St. Paul

Saint Paul, Minnesota, United States, 55102

Withdrawn

95

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

Withdrawn

96

University of Missouri Health Care

Columbia, Missouri, United States, 65212

Actively Recruiting

97

Mercy Hospital Springfield

Springfield, Missouri, United States, 65804

Actively Recruiting

98

Cox Medical Center South

Springfield, Missouri, United States, 65807

Actively Recruiting

99

Barnes Jewish Hospital

St Louis, Missouri, United States, 63110

Actively Recruiting

100

Mercy Hospital South

St Louis, Missouri, United States, 63128

Actively Recruiting

101

Mercy Hospital St. Louis

St Louis, Missouri, United States, 63141

Actively Recruiting

102

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68105

Actively Recruiting

103

JFK Medical Center

Edison, New Jersey, United States, 08820

Actively Recruiting

104

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Actively Recruiting

105

Cooperman Barnabas Medical Center

Livingston, New Jersey, United States, 07052

Actively Recruiting

106

Jersey Shore University Medical Center

Neptune City, New Jersey, United States, 07753

Actively Recruiting

107

Overlook Medical Center

Summit, New Jersey, United States, 07901

Actively Recruiting

108

Capital Health Regional Medical Center

Trenton, New Jersey, United States, 08638

Withdrawn

109

University of New Mexico Hospital

Albuquerque, New Mexico, United States, 87106

Suspended

110

Albany Medical Center

Albany, New York, United States, 12208

Actively Recruiting

111

Kings County Hospital Center

Brooklyn, New York, United States, 11203

Actively Recruiting

112

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States, 11215

Withdrawn

113

Maimonides Medical Center

Brooklyn, New York, United States, 11219

Terminated

114

NYU Langone Hospital - Brooklyn

Brooklyn, New York, United States, 11220

Actively Recruiting

115

Buffalo General Medical Center

Buffalo, New York, United States, 14202

Active, Not Recruiting

116

NYC Health + Hospitals/Elmhurst

Elmhurst, New York, United States, 11373

Actively Recruiting

117

North Shore University Hospital

Manhasset, New York, United States, 11030

Actively Recruiting

118

Mount Sinai West

New York, New York, United States, 10019

Actively Recruiting

119

The Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

120

NYP Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

121

NYP Weill Cornell Medical Center

New York, New York, United States, 10065

Actively Recruiting

122

Vassar Brothers Medical Center

Poughkeepsie, New York, United States, 12601

Terminated

123

Strong Memorial Hospital

Rochester, New York, United States, 14642

Actively Recruiting

124

Staten Island University Hospital - North Campus

Staten Island, New York, United States, 10305

Withdrawn

125

Stony Brook University Hospital

Stony Brook, New York, United States, 11794

Actively Recruiting

126

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

Actively Recruiting

127

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

128

Westchester Medical Center

Valhalla, New York, United States, 10595

Actively Recruiting

129

Burke Rehabilitation Center

White Plains, New York, United States, 10605

Actively Recruiting

130

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

131

Carolinas Medical Center

Charlotte, North Carolina, United States, 28204

Withdrawn

132

Presbyterian Medical Center

Charlotte, North Carolina, United States, 28204

Actively Recruiting

133

Duke University Hospital

Durham, North Carolina, United States, 27710

Actively Recruiting

134

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, United States, 27401

Actively Recruiting

135

ECU Health Medical Center

Greenville, North Carolina, United States, 27834

Actively Recruiting

136

New Hanover Regional Medical Center

Wilmington, North Carolina, United States, 28403

Actively Recruiting

137

Forsyth Medical Center

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

138

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

139

Cleveland Clinic Akron General

Akron, Ohio, United States, 44307

Actively Recruiting

140

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

141

Good Samaritan Hospital

Cincinnati, Ohio, United States, 45220

Actively Recruiting

142

UH Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

143

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Actively Recruiting

144

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

145

OSU Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

146

Riverside Methodist Hospital

Columbus, Ohio, United States, 43214

Actively Recruiting

147

OU Medical Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

148

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States, 73120

Actively Recruiting

149

Ascension St. John Medical Center

Tulsa, Oklahoma, United States, 74104

Actively Recruiting

150

St. John Medical Center

Tulsa, Oklahoma, United States, 74104

Actively Recruiting

151

Oregon Health & Science University Hospital

Portland, Oregon, United States, 92739

Actively Recruiting

152

Providence St. Vincent Medical Center

Portland, Oregon, United States, 97213

Actively Recruiting

153

PeaceHealth Sacred Heart Medical Center - RiverBend

Springfield, Oregon, United States, 97477

Actively Recruiting

154

Jefferson Abington Hospital

Abington, Pennsylvania, United States, 19001

Actively Recruiting

155

Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, United States, 18103

Withdrawn

156

Geisinger Medical Center

Danville, Pennsylvania, United States, 17822

Withdrawn

157

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

158

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

159

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Withdrawn

160

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

161

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

162

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Terminated

163

Medical University of South Carolina University Hospital

Charleston, South Carolina, United States, 29425

Actively Recruiting

164

Greenville Hospital System

Greenville, South Carolina, United States, 29605

Actively Recruiting

165

Avera Research Institute

Sioux Falls, South Dakota, United States, 57108

Actively Recruiting

166

Erlanger Health System

Chattanooga, Tennessee, United States, 37403

Withdrawn

167

Fort Sanders Regional Medical Center

Knoxville, Tennessee, United States, 37916

Actively Recruiting

168

Methodist University Hospital

Memphis, Tennessee, United States, 38104

Actively Recruiting

169

Semmes Murphey Main Campus

Memphis, Tennessee, United States, 38120

Actively Recruiting

170

Vanderbilt University Hospital

Nashville, Tennessee, United States, 37232

Actively Recruiting

171

St. David's Medical Center

Austin, Texas, United States, 78705

Withdrawn

172

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Withdrawn

173

Baylor College of Medicine Medical Center

Houston, Texas, United States, 77030

Withdrawn

174

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

175

Memorial Hermann Texas Medical Center

Houston, Texas, United States, 77030

Actively Recruiting

176

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

177

University of Utah Healthcare

Salt Lake City, Utah, United States, 84112

Actively Recruiting

178

The University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Actively Recruiting

179

UVA Medical Center

Charlottesville, Virginia, United States, 22908

Actively Recruiting

180

Inova Fairfax Hospital

Falls Church, Virginia, United States, 22042

Actively Recruiting

181

Bon Secours St. Mary's Hospital

Richmond, Virginia, United States, 23226

Actively Recruiting

182

VCU Medical Center

Richmond, Virginia, United States, 23298

Suspended

183

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Withdrawn

184

Harborview Medical Center

Seattle, Washington, United States, 98104

Actively Recruiting

185

Swedish Medical Center - Cherry Hill Campus

Seattle, Washington, United States, 98122

Withdrawn

186

J.W. Ruby Memorial Hospital

Morgantown, West Virginia, United States, 26506

Actively Recruiting

187

Froedtert Hospital

Milwaukee, Wisconsin, United States, 53226

Withdrawn

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Research Team

K

Kevin N Sheth, MD

CONTACT

H

Hooman Kamel, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery | DecenTrialz