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Coronary Artery DiseasePhase 3ASPECTNCT00990327

Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI

A Phase 3 study testing Apadenoson SPECT-MPI and Adenosine SPECT-MPI in people with Coronary Artery Disease, run by Forest Laboratories at 122 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial SPECT-Imaging to detect defects in the supply of blood to the heart muscle (myocardial perfusion defects). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Apadenoson SPECT-MPI and Adenosine SPECT-MPI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
863 participants
Where
122 sitesin 2 countries
Study dates
Nov 2009to Apr 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • High pretest probability of CAD based on the ACC/AHA guidelines for relative risk, or past medical h/o CAD

Who cannot join

  • Ingestion of a caffeinated or methylxanthine food substance (e.g. chocolate, cocoa) within 24 hours before receiving apadenoson or adenosine
  • Treatment with dipyridamole within 24 hours, or theophylline, aminophylline, or pentoxifylline within 72 hours (or 4 half-lives, whichever is longer) prior to receiving apadenoson or adenosine
  • Acute MI, new onset of ischemia or PCI within 30 days prior to SPECT-MPI at either Period 1 or Period 2; or CABG within 90 days prior to SPECT-MPI at either Period 1 or Period 2
  • Active severe asthma or severe chronic obstructive pulmonary disease (COPD) which, in the Investigator's opinion, places the subject at risk for severe bronchoconstriction
  • History or evidence of clinically significant cardiac condition and rhythm disorder, in the absence of a functioning permanently implanted pacemaker
  • Hemodynamically significant valvular disease, outflow tract obstruction, or uncontrolled severe hypertension
Show all 10Show fewer
  • Current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug
  • Subject with past medical history of hepatitis B or C, or recent hepatitis A
  • Pretreatment hypotension (systolic BP < 90 mm Hg) or tachycardia (HR > 100 bpm)
  • Known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent

Trial locations and contacts

122 sites in 2 countries.

122 sites in 2 countries

United States103 sites

  • Forest Investigative Site 235

    Akron, Ohio, 44304

  • Forest Investigative Site 115

    Albany, New York, 12205

  • Forest Investigative Site 202

    Alexandria, Louisiana, 71301

  • Forest Investigative Site 128

    Amarillo, Texas, 79106

  • Forest Investigative Site 114

    Auburn, Maine, 04210

  • Forest Investigative Site 155

    Augusta, Georgia, 30912

  • Forest Investigative Site 193

    Baltimore, Maryland, 21208

  • Forest Investigative Site 190

    Bend, Oregon, 97701

  • Forest Investigative Site 152

    Birmingham, Alabama, 35294

  • Forest Investigative Site 137

    Boise, Idaho, 83712

  • Forest Investigative Site 138

    Boise, Idaho, 83712

  • Forest Investigative Site 212

    Buffalo, New York, 14215

  • Forest Investigative Site 213

    Camp Hill, Pennsylvania, 17011

  • Forest Investigative Site 149

    Charleston, South Carolina, 29425

  • Forest Investigative Site 210

    Charlottesville, Virginia, 22908

  • Forest Investigative Site 227

    Chicago, Illinois, 60612

  • Forest Investigative Site163

    Columbus, Ohio, 43210

  • Forest Investigative Site 161

    Columbus, Ohio, 43214

  • Forest Investigative Site 257

    Covington, Louisiana, 70433

  • Forest Investigative Site 248

    Crestview Hills, Kentucky, 41017

  • Forest Investigative Site 199

    Cumming, Georgia, 30041

  • Forest Investigative Site 205

    Daytona Beach, Florida, 32114

  • Forest Investigative Site 143

    Detroit, Michigan, 48202

  • Forest Investigative Site 233

    Edgewater, Florida, 32141

  • Forest Investigative Site 214

    Fargo, North Dakota, 58122

  • Forest Investigative Site 164

    Gainesville, Florida, 32605

  • Forest Investigative Site 252

    Grapevine, Texas, 76051

  • Forest Investigative Site 132

    Hartford, Connecticut, 06102

  • Forest Investigative Site 116

    Honolulu, Hawaii, 96813

  • Forest Investigative Site 113

    Indianapolis, Indiana, 46260

  • Forest Investigative Site 120

    Jacksonville, Florida, 32207

  • Forest Investigative Site 198

    Jacksonville, Florida, 32209

  • Forest Investigative Site 118

    Jacksonville, Florida, 32216

  • Forest Investigative Site 124

    Jacksonville, Florida, 32216

  • Forest Investigative Site 125

    Jacksonville, Florida, 32258

  • Forest Investigative Site 126

    Jacksonville Beach, Florida, 32250

  • Forest Investigative Site 167

    Johnson City, Tennessee, 37604

  • Forest Investigative Site 192

    Johnson City, Tennessee, 37604

  • Forest Investigative Site 228

    Joliet, Illinois, 60435

  • Forest Investigative Site 230

    Jonesboro, Arkansas, 72401

  • Forest Investigative Site 176

    Kansas City, Missouri, 64132

  • Forest Investigative Site 165

    Kingston, New York, 12401

  • Forest Investigative Site 108

    La Mesa, California, 91942

  • Forest Investigative Site 153

    Little Rock, Arkansas, 72204

  • Forest Investigative Site 156

    Lorain, Ohio, 44053

  • Forest Investigative Site 144

    Madison, Wisconsin, 53715

  • Forest Investigative Site 224

    Manhasset, New York, 11030

  • Forest Investigative Site 139

    Massapequa, New York, 11758

  • Forest Investigative Site 200

    McKinney, Texas, 75069

  • Forest Investigative Site 180

    Melbourne, Florida, 32901

  • Forest Investigative Site 183

    Miami, Florida, 33136

  • Forest Investigative Site 106

    Miami, Florida, 33173

  • Forest Investigative Site 111

    Mission Viejo, California, 92691

  • Forest Investigative Site 188

    Missoula, Montana, 59802

  • Forest Investigative Site 250

    Mobile, Alabama, 36608

  • Forest Investigative Site 234

    Murrieta, California, 92562

  • Forest Investigative Site 201

    Naples, Florida, 34119

  • Forest Investigative Site 102

    Newark, Delaware, 19713

  • Forest Investigative Site 182

    Oklahoma City, Oklahoma, 73109

  • Forest Investigative Site 133

    Overland Park, Kansas, 66209

  • Forest Investigative Site 241

    Owensboro, Kentucky, 42303

  • Forest Investigative Site 207

    Petoskey, Michigan, 49770

  • Forest Investigative Site 154

    Philadelphia, Pennsylvania, 19102

  • Forest Investigative Site 134

    Philadelphia, Pennsylvania, 19140

  • Forest Investigative Site 218

    Philadelphia, Pennsylvania, 19141

  • Forest Investigative Site 223

    Phoenix, Arizona, 85006

  • Forest Investigative Site 191

    Phoenix, Arizona, 85020

  • Forest Investigative Site 160

    Pittsburgh, Pennsylvania, 15213

  • Forest Investigative Site 181

    Plano, Texas, 75024

  • Forest Investigative Site 217

    Portland, Oregon, 97239

  • Forest Investigative Site 236

    Provo, Utah, 84604

  • Forest Investigative Site 208

    Raleigh, North Carolina, 27610

  • Forest Investigative Site 110

    Roanoke, Virginia, 24014

  • Forest Investigative Site 146

    Roseville, California, 95661

  • Forest Investigative Site 225

    Sacramento, California, 95816

  • Forest Investigative Site 122

    Sacramento, California, 95825

  • Forest Investigative Site 177

    Saint Louis Park, Minnesota, 55416

  • Forest Investigative Site 253

    San Antonio, Texas, 78215

  • Forest Investigative Site 185

    Sandusky, Ohio, 44870

  • Forest Investigative Site 249

    Sanford, North Carolina, 27330

  • Forest Investigative Site 105

    Santa Rosa, California, 95405

  • Forest Investigative Site 107

    Scarborough, Maine, 04074

  • Forest Investigative Site 151

    Seattle, Washington, 98195

  • Forest Investigative Site 187

    Sellersville, Pennsylvania, 18960

  • Forest Investigative Site 172

    Simpsonville, South Carolina, 29681

  • Forest Investigative Site 109

    South Portland, Maine, 04106

  • Forest Investigative Site 229

    Spartanburg, South Carolina, 29302

  • Forest Investigative Site 142

    Spokane, Washington, 99204

  • Forest Investigative Site 159

    St Louis, Missouri, 63110

  • Forest Investigative Site 186

    Sugar Land, Texas, 77479

  • Forest Investigative Site 240

    Tampa, Florida, 33609

  • Forest Investigative Site 231

    Tomball, Texas, 77375

  • Forest Investigative Site 232

    Tomball, Texas, 77375

  • Forest Investigative Site 204

    Tucker, Georgia, 30084

  • Forest Investigative Site 131

    Tupelo, Mississippi, 38801

  • Forest Investigative Site 168

    Valparaiso, Indiana, 46383

  • Forest Investigative Site 196

    Walnut Creek, California, 94598

  • Forest Investigative Site 238

    Wellington, Florida, 33449

  • Forest Investigative Site 171

    West Des Moines, Iowa, 50266

  • Forest Investigative Site 101

    Westlake, Ohio, 44145

  • Forest investigative Site 197

    Westminster, Maryland, 21157

  • Forest Investigative Site 173

    Winfield, Illinois, 60190

  • Forest Investigative Site 117

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Brazil19 sites

  • Forest Investigative Site 308

    Belo Horizonte - MG, 30150-221

  • Forest Investigative Site 317

    Brasília - DF, 70390-700

  • Forest Investigative Site 311

    Campinas, 13060-803

  • Forest Investigative Site 307

    Curitiba, Paraná, 80010-030

  • Forest Investigative Site 313

    Curitiba, 80050-010

  • Forest Investigative Site 305

    Curitiba, 83430-000

  • Forest Investigative Site 314

    Curitiba - PR, 80320-320

  • Forest Investigative Site 316

    Niterói, 24020-350

  • Forest Investigative Site 309

    Passo Fundo - RS, 99010-080

  • Forest Investigative Site 318

    Porto Alegre - RS, 90020-090

  • Forest Investigative Site 310

    Porto Alegre - RS, 90035-903

  • Forest Investigative Site 315

    Rio de Janeiro, 22251-030

  • Forest Investigative Site 319

    Rio de Janeiro - RJ, 22240-006

  • Forest Investigative Site 304

    Rio de Janeiro - RJ, 22280-020

  • Forest Investigative Site 306

    Salvador, Estado de Bahia, 41148-900

  • Forest Investigative Site 301

    Salvador - BA, 41810-010

  • Forest Investigative Site 303

    São José, 88103-460

  • Forest Investigative Site 302

    São Paulo - SP, 04012-180

  • Forest Investigative Site 312

    São Paulo - SP, 05403-000

Other trials in Brazil

About this study

Official title: The ASPECT Trial: A Phase III, Randomized, Double-Blind Crossover Trial of Apadenoson for the Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)

The purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial SPECT-Imaging to detect defects in the supply of blood to the heart muscle (myocardial perfusion defects). The study will also look at whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.

Read the detailed description

Adenosine is an effective vasodilator used in SPECT-Myocardial Perfusion Imaging (SPECT-MPI). However, it produces transient symptoms that are poorly tolerated by most subjects. PGxHealth has designed a multi-center, randomized crossover, double-blind study to compare the safety and effectiveness of apadenoson to adenosine (Adenoscan®) in SPECT-MPI. Subjects who are clinical candidates for SPECT-MPI will be enrolled to undergo two sequential SPECT-MPI studies. The first study will use adenosine as the stress agent in approximately 1300 subjects. Eligible subjects will then be randomized in a 1:2 assignment ratio to receive a second SPECT-MPI using either adenosine or apadenoson as the pharmacologic stress agent, with the goal of obtaining a total of 753 subjects who complete both studies. The similarity of the results from the two adenosine:adenosine stress tests will be compared to those from the adenosine:apadenoson tests to assess efficacy. The incidence and intensity of commonly reported side effects will be compared to evaluate improved tolerability.

Being tested
Apadenoson SPECT-MPI, Adenosine SPECT-MPI
Keywords
Coronary artery disease, Myocardial Perfusion Imaging
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apadenoson SPECT-MPIDrug

    Also called DPC-A78445-00, DPH-068645-01, ATL146e, DWH 146e

    Apadenoson single bolus IV injection 100 or 150 ug

  • Adenosine SPECT-MPIDrug

    Also called Adenoscan

    Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute.

Study groups in NCT00990327
Study groupRoleWhat they receive
ApadenosonExperimentalIn period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with apadenoson or the active comparator: adenosine.
Receives: Drug: Apadenoson SPECT-MPI; Drug: Adenosine SPECT-MPI
AdenosineActive comparatorIn period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with apadenoson or the active comparator: adenosine.
Receives: Drug: Apadenoson SPECT-MPI; Drug: Adenosine SPECT-MPI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of myocardial perfusion defect as based on SPECT-MPI

    Measured: Up to 2 hours after study drug administration in Period 1 and 2

Secondary outcomes (1)

  1. Incidence and patient rated intensity of most commonly reported side effects (e.g. dyspnea, flushing, chest pain, headache) associated with use of adenosine compared to apadenoson in SPECT-MPI

    Measured: 1 hour after Period 2 study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
863 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00990327
Sponsor's protocol ID
PGX-III-AP-001
Acronym
ASPECT
Status last verified
Apr 2012
First submitted
2 Oct 2009
Last updated
1 May 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apadenoson SPECT-MPI and Adenosine SPECT-MPI in people with Coronary Artery Disease, run by Forest Laboratories at 122 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of myocardial perfusion defect as based on SPECT-MPI (time frame: Up to 2 hours after study drug administration in Period 1 and 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00990327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.

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