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Coronary Artery DiseasePhase 3ASPECT2NCT01313572

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 86 sites in 5 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 (SPECT-MPI)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
197 participants
Where
86 sitesin 5 countries
Study dates
Aug 2011to 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

  • Referred for a clinically indicated rest/pharmacologic stress SPECT-MPI test
  • High pretest probability (90% or greater) of CAD based on the ACC/AHA guidelines for relative risk, or past medical h/o CAD

Who cannot join

  • 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
  • Known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent
  • Current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug

Trial locations and contacts

86 sites in 5 countries.

86 sites in 5 countries

United States45 sites

  • Forest Investigative Site 125

    Albuquerque, New Mexico, 87108

  • Forest Investigative Site 124

    Annapolis, Maryland, 21401

  • Forest Investigative Site 121

    Auburn, Maine, 04210

  • Forest Investigative Site 148

    Beverly Hills, California, 90210

  • Forest Investigative Site 153

    Camp Hill, Pennsylvania, 17011

  • Forest Investigative Site 101

    Clearwater, Florida, 33756

  • Forest Investigative Site 166

    Covington, Louisiana, 70433

  • Forest Investigative Site 118

    Cumming, Georgia, 30041

  • Forest Investigative Site 163

    Daytona Beach, Florida, 32117

  • Forest Investigative Site 156

    Denver, Colorado, 80206

  • Forest Investigative Site 104

    Detroit, Michigan, 48201

  • Forest Investigative Site 134

    Detroit, Michigan, 48202

  • Forest Investigative Site 135

    Edgewater, Florida, 32141

  • Forest Investigative Site 109

    Hammond, Louisiana, 70403

  • Forest Investigative Site 149

    Hollywood, Maryland, 20636

  • Forest Investigative Site 107

    Houston, Texas, 77024

  • Forest Investigative Site 129

    Houston, Texas, 77070

  • Forest Investigative Site 102

    Inverness, Florida, 34452

  • Forest Investigative Site 151

    Jacksonville, Florida, 32209

  • Forest Investigative Site 145

    Johnson City, Tennessee, 37604

  • Forest Investigative Site 142

    Kansas City, Missouri, 64114

  • Forest Investigative Site 113

    Little Rock, Arkansas, 72204

  • Forest Investigative Site 154

    Los Angeles, California, 90048

  • Forest Investigative Site 105

    Melbourne, Florida, 32901

  • Forest Investigative Site 143

    Melbourne, Florida, 32901

  • Forest Investigative Site 137

    Miami, Florida, 33136

  • Forest Investigative Site 103

    Miami, Florida, 33173

  • Forest Investigative Site 131

    Mission Viejo, California, 92691

  • Forest Investigative Site 123

    Naples, Florida, 34119

  • Forest Investigative Site 140

    Nashville, Tennessee, 37203

  • Forest Investigative Site 162

    New Brunswick, New Jersey, 08901

  • Forest Investigative Site 108

    New Haven, Connecticut, 06510

  • Forest Investigative Site 110

    New York, New York, 10032

  • Forest Investigative Site 111

    Newark, Delaware, 19713

  • Forest Investigative Site 138

    Phoenix, Arizona, 85006

  • Forest Investigative Site 146

    Phoenix, Arizona, 85020

  • Forest Investigative Site 152

    Pittsburgh, Pennsylvania, 15213

  • Forest Investigative Site 115

    Plano, Texas, 75024

  • Forest Investigative Site 144

    Provo, Utah, 84604

  • Forest Investigative Site 159

    Rochester, Minnesota, 55905

  • Forest Investigative Site 161

    Safety Harbor, Florida, 34695

  • Forest Investigative Site 122

    Slidell, Louisiana, 70458

  • Forest Investigative Site 150

    Tomball, Texas, 77375

  • Forest Investigative Site 119

    Tucker, Georgia, 30084

  • Forest Investigative Site 120

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Brazil16 sites

  • Forest Investigative Site 307

    Belo Horizonte, 30130-100

  • Forest Investigative Site 308

    Belo Horizonte, 30140-000

  • Forest Investigative Site 314

    Curitiba, Paraná, 80010-030

  • Forest Investigative Site 312

    Curitiba, Paraná, 80320-320

  • Forest Investigatie Site 301

    Curitiba, 80050-010

  • Forest Investigative Site 306

    Goiânia, 74823-470

  • Forest Investigative Site 310

    Maceió, 57021-500

  • Forest Investigative Site 302

    Porto Alegre, 90610-000

  • Forest Investigative Site 304

    Recife, 52010-010

  • Forest Investigative Site 315

    Rio de Janeiro, 22251-050

  • Forest Investigative Site 311

    Rio de Janeiro, 22640-102

  • Forest Investigative Site 303

    Salvador, 40050-410

  • Forest Investigative Site 309

    São José do Rio Preto, São Paulo, 15015-210

  • Forest Investigative Site 305

    São José do Rio Preto, 15015-205

  • Forest Investigative Site 313

    São Paulo, 04012-180

  • Forest Investigative Site 316

    São Paulo, 05403-000

Other trials in Brazil

Argentina14 sites

  • Forest Investigative Site 209

    Buenos Aires, 1177AEJ

  • Forest Investigative Site 212

    Buenos Aires, 1201

  • Forest Investigative Site 205

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1122AAL

  • Forest Investigative Site 211

    Córdoba, X5000AAX

  • Forest Investigative Site 207

    Córdoba, X5000JJS

  • Forest Investigative Site 203

    Córdoba, X5003FGG

  • Forest Investigative Site 201

    Godoy Cruz, M5501AAJ

  • Forest Investigative Site 202

    Godoy Cruz, M5501AAJ

  • Forest Investigative Site 214

    La Plata, B1925XAC

  • Forest Investigative Site 210

    Mar del Plata, B7600FZD

  • Forest Investigative Site 208

    Rosario, Santa Fe Province, S2000DIF

  • Forest Investigative Site 204

    Rosario, Santa Fe Province, S2000ODA

  • Forest Investigative Site 213

    San Isidro, B1642CAD

  • Forest Investigative Site 206

    Santa Fe, S3000AOL

Other trials in Argentina

Netherlands9 sites

  • Forest Investigative Site 407

    Amsterdam, 1061 AE

  • Forest Investigative Site 403

    Apeldoorn, Lukas, 7334 DZ

  • Forest Investigative Site 405

    Delft, 2625 AD

  • Forest Investigative Site 401

    Doetinchem, 7009 BL

  • Forest Investigative Site 402

    Gouda, Bleuland, 2803 HH

  • Forest Investigative Site 408

    Hengelo, 7555 DL

  • Forest Investigative Site 404

    Hoogeveen, 7909 AA

  • Forest Investigative Site 406

    Maastricht, 6229 HX

  • Forest Investigative Site 409

    Rotterdam, 3045 PM

Other trials in Netherlands

Belgium2 sites

  • Forest Investigative Site 501

    Aalst, 9300

  • Forest Investigative Site 503

    Brussels, 1200

Other trials in Belgium

About this study

Official title: The ASPECT2 Trial: A Phase 3, Randomized, Double-Blind 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 (SPECT-MPI)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. This is a multi-center, randomized double-blind study to compare the tolerability 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 1250 subjects. Eligible subjects will then be randomized in a 1:1 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 670 subjects who complete both studies. The agreement of the results from the two adenosine:adenosine stress tests will be compared to that 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 BMS068645, DPC-A78445-00, DPH-068645-01, ATL146e

    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 NCT01313572
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
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 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 based on SPECT-MPI

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

Secondary outcomes (1)

  1. Incidence and subject rated intensity of most commonly reported side effects associated with use of adenosine compared to apadenoson in SPECT-MPI

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

Timeline

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

  1. First posted11 Mar 2011 (estimated)
  2. Study startAug 2011
  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
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01313572
Sponsor's protocol ID
PGX-III-AP-002
Acronym
ASPECT2
Status last verified
Apr 2012
First submitted
4 Mar 2011
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 86 sites in 5 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 2 inclusion and 6 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 86 sites in United States, Brazil, Argentina, Netherlands, Belgium. 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 based on SPECT-MPI (time frame: Up to 2 hours after study drug administration in Period 1 and Period 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 NCT01313572.

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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