Saphenous Vein Graft AtherosclerosisPhase 4ASAP-SVGNCT03542110

The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial

A Phase 4 study testing Alirocumab 150 MG/ML subcutaneous injection in people with Saphenous Vein Graft Atherosclerosis, run by Minneapolis Heart Institute Foundation at 4 sites in United States.

Terminated

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

Official record

Search all trials

Trial summary

This is a phase IV, multi-center, double-blind, randomized, placebo- controlled study evaluating the effect of alirocumab on SVG atherosclerotic disease burden, as assessed by IVUS at baseline and following 78 weeks of treatment in subjects with at least one intermediate SVG lesion receiving optimal statin therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Saphenous Vein Graft Atherosclerosis
What is being tested?: Alirocumab 150 MG/ML subcutaneous injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 4 sitesUnited States
Study dates: 4 Aug 2018to 31 Jul 2020
Phase: Phase 4
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

Age 18 years or greater.
Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
Undergoing clinically-indicated coronary and SVG angiography.
Have at least one target saphenous vein graft with an intermediate SVG lesion (defined as a lesion with 30-60% angiographic diameter stenosis) amenable to examination with IVUS. The SVG should have no thrombus or ulceration and should not be considered responsible for the patient's clinical presentation and referral for angiography.
Receiving optimal statin therapy defined as use of a high intensity statin (atorvastatin 40-80 mg daily or rosuvastatin 20-40 mg daily), any statin therapy with achieved LDL-C level <70mg/dL, or maximally-tolerated statin dose for patients who are statin intolerant statin.

Who cannot join

Positive pregnancy test or breast-feeding.
Coexisting conditions that limit life expectancy to less than 18 months or that could affect a patient's compliance with the protocol.
Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.
Severe peripheral arterial disease limiting vascular access.
History of allergic reaction to iodine-based contrast agents that cannot be premedicated.
Known hypersensitivity to alirocumab.
Any prior use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor therapy.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Atlanta VA Medical Center
Atlanta, Georgia, 30033
Dallas VA Medical Center
Dallas, Texas, 75216
Minneapolis Heart Institute/ Abbott North Western Hospital-Allina Health
Minneapolis, Minnesota, 55407
San Francisco VA Medical Center
San Francisco, California, 94121

Other trials in United States

About this study

Official title: Effect of Alirocumab on Saphenous Vein Graft Atherosclerosis: The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial

Conditions: Saphenous Vein Graft Atherosclerosis
Being tested: Alirocumab 150 MG/ML subcutaneous injection, Matching Placebo subcutaneous injection

What participants receive

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

Alirocumab 150 MG/ML subcutaneous injectionDrug
Also called Praluent, Study Drug
Single-dose, pre-filled, disposable, subcutaneous injection pen
Matching Placebo subcutaneous injectionDrug
Also called Placebo, Study Drug
Single-dose, pre-filled, disposable, subcutaneous injection pen

Study groups in NCT03542110
Study group	Role	What they receive
Alirocumab 150 MG/ML subcutaneous injection	Active comparator	Alirocumab 150 mg subcutaneously every 2 weeks Receives: Drug: Alirocumab 150 MG/ML subcutaneous injection
Matching Placebo subcutaneous injection	Placebo comparator	Matching placebo subcutaneously every 2 weeks Receives: Drug: Matching Placebo subcutaneous injection

What is being measured

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

Nominal change in intermediate SVG lesion percent atheroma volume (PAV) from baseline to 78 weeks post randomization, as assessed by intravascular ultrasonography (IVUS).
To evaluate the effect of alirocumab on the change in burden of saphenous vein graft (SVG) atherosclerosis as measured by percent atheroma volume (PAV) in patients with intermediate SVG lesions who are undergoing clinically-indicated coronary angiography and are receiving optimal statin therapy.
Measured: 78 weeks

Secondary outcomes (3)

Nominal change in TAV and normalized TAV of an intermediate SVG lesion from baseline to 78 weeks
evaluate the effect of alirocumab on the change in total and normalized total atheroma volume (TAV) of an intermediate SVG lesion
Measured: 78 weeks
Angiographic failure of target SVG lesion from baseline to 78 weeks.
To evaluate the effect of alirocumab on the incidence of angiographic failure of an intermediate target SVG lesion.
Measured: 78 weeks
Incidence of target SVG failure and major adverse cardiac events.
To evaluate the effect of alirocumab on the incidence of target SVG failure (defined as the composite of death, myocardial infarction, and target lesion revascularization) and the incidence of major adverse cardiac events (MACE, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during follow-up.
Measured: Randomization to 80 weeks

Timeline

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

4 Aug 201831 Jul 2020

First posted31 May 2018
Study start4 Aug 2018
Primary completion30 Jun 2020
Study completion31 Jul 2020

Why it stopped: Withdrawal of medication and funding support by Sponsor

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Saphenous Vein Graft AtherosclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03542110
Sponsor's protocol ID: ASAP-SVG, QR#32711/1
Acronym: ASAP-SVG
Status last verified: Sep 2021
First submitted: 18 May 2018
Last updated: 16 Sep 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Domanski MJ, Borkowf CB, Campeau L, Knatterud GL, White C, Hoogwerf B, Rosenberg Y, Geller NL. Prognostic factors for atherosclerosis progression in saphenous vein grafts: the postcoronary artery bypass graft (Post-CABG) trial. Post-CABG Trial Investigators. J Am Coll Cardiol. 2000 Nov 15;36(6):1877-83. doi: 10.1016/s0735-1097(00)00973-6.
PubMed 11092659
DeFrances CJ, Lucas CA, Buie VC, Golosinskiy A. 2006 National Hospital Discharge Survey. Natl Health Stat Report. 2008 Jul 30;(5):1-20.
PubMed 18841653
Alexander JH, Hafley G, Harrington RA, Peterson ED, Ferguson TB Jr, Lorenz TJ, Goyal A, Gibson M, Mack MJ, Gennevois D, Califf RM, Kouchoukos NT; PREVENT IV Investigators. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA. 2005 Nov 16;294(19):2446-54. doi: 10.1001/jama.294.19.2446.
PubMed 16287955
Sabik JF 3rd. Understanding saphenous vein graft patency. Circulation. 2011 Jul 19;124(3):273-5. doi: 10.1161/CIRCULATIONAHA.111.039842. No abstract available.
PubMed 21768550
Shroyer AL, Grover FL, Hattler B, Collins JF, McDonald GO, Kozora E, Lucke JC, Baltz JH, Novitzky D; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. On-pump versus off-pump coronary-artery bypass surgery. N Engl J Med. 2009 Nov 5;361(19):1827-37. doi: 10.1056/NEJMoa0902905.
PubMed 19890125
Goldman S, Zadina K, Moritz T, Ovitt T, Sethi G, Copeland JG, Thottapurathu L, Krasnicka B, Ellis N, Anderson RJ, Henderson W; VA Cooperative Study Group #207/297/364. Long-term patency of saphenous vein and left internal mammary artery grafts after coronary artery bypass surgery: results from a Department of Veterans Affairs Cooperative Study. J Am Coll Cardiol. 2004 Dec 7;44(11):2149-56. doi: 10.1016/j.jacc.2004.08.064.
PubMed 15582312
Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.
PubMed 8772748
Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Holper EM, Haagen D, Saeed B, Iturbe JM, Shunk K, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S, Brilakis ES. Clinical presentation and angiographic characteristics of saphenous vein graft failure after stenting: insights from the SOS (stenting of saphenous vein grafts) trial. JACC Cardiovasc Interv. 2009 Sep;2(9):855-60. doi: 10.1016/j.jcin.2009.06.014.
PubMed 19778774
Brilakis ES, Lee M, Mehilli J, Marmagkiolis K, Rodes-Cabau J, Sachdeva R, Kotsia A, Christopoulos G, Rangan BV, Mohammed A, Banerjee S. Saphenous vein graft interventions. Curr Treat Options Cardiovasc Med. 2014 May;16(5):301. doi: 10.1007/s11936-014-0301-x.
PubMed 24643432
Ellis SG, Brener SJ, DeLuca S, Tuzcu EM, Raymond RE, Whitlow PL, Topol EJ. Late myocardial ischemic events after saphenous vein graft intervention--importance of initially "nonsignificant" vein graft lesions. Am J Cardiol. 1997 Jun 1;79(11):1460-4. doi: 10.1016/s0002-9149(97)00171-9.
PubMed 9185633
Knatterud GL, White C, Geller NL, Campeau L, Forman SA, Domanski M, Forrester JS, Gobel FL, Herd JA, Hickey A, Hoogwerf BJ, Hunninghake DB, Terrin ML, Rosenberg Y. Angiographic changes in saphenous vein grafts are predictors of clinical outcomes. Am Heart J. 2003 Feb;145(2):262-9. doi: 10.1067/mhj.2003.113.
PubMed 12595843
Rodes-Cabau J, Facta A, Larose E, DeLarochelliere R, Dery JP, Nguyen CM, Roy L, Proulx G, Gleeton O, Barbeau G, Noel B, Rouleau J, Boudreault JR, Bertrand OF. Predictors of aorto-saphenous vein bypass narrowing late after coronary artery bypass grafting. Am J Cardiol. 2007 Aug 15;100(4):640-5. doi: 10.1016/j.amjcard.2007.03.080. Epub 2007 Jun 27.
PubMed 17697821
Rodes-Cabau J, Bertrand OF, Larose E, Dery JP, Rinfret S, Bagur R, Proulx G, Nguyen CM, Cote M, Landcop MC, Boudreault JR, Rouleau J, Roy L, Gleeton O, Barbeau G, Noel B, Courtis J, Dagenais GR, Despres JP, DeLarochelliere R. Comparison of plaque sealing with paclitaxel-eluting stents versus medical therapy for the treatment of moderate nonsignificant saphenous vein graft lesions: the moderate vein graft lesion stenting with the taxus stent and intravascular ultrasound (VELETI) pilot trial. Circulation. 2009 Nov 17;120(20):1978-86. doi: 10.1161/CIRCULATIONAHA.109.874057. Epub 2009 Nov 2.
PubMed 19884468
Rodes-Cabau J, Bertrand OF, Larose E, Dery JP, Rinfret S, Urena M, Jerez M, Nombela-Franco L, Ribeiro HB, Allende R, Proulx G, Nguyen CM, Boudreault JR, Rouleau J, Roy L, Gleeton O, Barbeau G, Noel B, Cote M, Despres JP, Dagenais GR, DeLarochelliere R. Five-year follow-up of the plaque sealing with paclitaxel-eluting stents vs medical therapy for the treatment of intermediate nonobstructive saphenous vein graft lesions (VELETI) trial. Can J Cardiol. 2014 Jan;30(1):138-45. doi: 10.1016/j.cjca.2013.11.002. Epub 2013 Nov 6.
PubMed 24365196
Kotsia AP, Rangan BV, Christopoulos G, Coleman A, Roesle M, Cipher D, de Lemos JA, McGuire DK, Packer M, Banerjee S, Brilakis ES. Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis: Insights from the Atherosclerosis Lesion Progression Intervention Using Niacin Extended Release in Saphenous Vein Grafts (ALPINE-SVG) Pilot Trial. J Invasive Cardiol. 2015 Oct;27(10):E204-10.
PubMed 26429851

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Alirocumab on Saphenous Vein Graft Atherosclerosis: The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial
ClinicalTrials.gov ID: NCT03542110
Acronym / sponsor ID: ASAP-SVG / ASAP-SVG, QR#32711/1
Conditions: Saphenous Vein Graft Atherosclerosis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Withdrawal of medication and funding support by Sponsor
Enrolment: 46 participants (actual)
Lead sponsor: Minneapolis Heart Institute FoundationUniversity, hospital or other
Collaborators: Regeneron Pharmaceuticals
Study start: 4 Aug 2018 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 31 Jul 2020 (actual)
First posted: 31 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Alirocumab 150 MG/ML subcutaneous injection	Active comparator	Drug: Alirocumab 150 MG/ML subcutaneous injectionAlirocumab 150 mg subcutaneously every 2 weeks
Matching Placebo subcutaneous injection	Placebo comparator	Drug: Matching Placebo subcutaneous injectionMatching placebo subcutaneously every 2 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 18 years or greater.
Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
Undergoing clinically-indicated coronary and SVG angiography.
Have at least one target saphenous vein graft with an intermediate SVG lesion (defined as a lesion with 30-60% angiographic diameter stenosis) amenable to examination with IVUS. The SVG should have no thrombus or ulceration and should not be considered responsible for the patient's clinical presentation and referral for angiography.
Receiving optimal statin therapy defined as use of a high intensity statin (atorvastatin 40-80 mg daily or rosuvastatin 20-40 mg daily), any statin therapy with achieved LDL-C level <70mg/dL, or maximally-tolerated statin dose for patients who are statin intolerant statin.

Key exclusion criteria (7 listed)

Positive pregnancy test or breast-feeding.
Coexisting conditions that limit life expectancy to less than 18 months or that could affect a patient's compliance with the protocol.
Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.
Severe peripheral arterial disease limiting vascular access.
History of allergic reaction to iodine-based contrast agents that cannot be premedicated.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alirocumab 150 MG/ML subcutaneous injectionAlso: Praluent, Study DrugSingle-dose, pre-filled, disposable, subcutaneous injection pen	Drug	Alirocumab 150 MG/ML subcutaneous injection
Matching Placebo subcutaneous injectionAlso: Placebo, Study DrugSingle-dose, pre-filled, disposable, subcutaneous injection pen	Drug	Matching Placebo subcutaneous injection

Primary outcome

Nominal change in intermediate SVG lesion percent atheroma volume (PAV) from baseline to 78 weeks post randomization, as assessed by intravascular ultrasonography (IVUS).
Time frame: 78 weeks
To evaluate the effect of alirocumab on the change in burden of saphenous vein graft (SVG) atherosclerosis as measured by percent atheroma volume (PAV) in patients with intermediate SVG lesions who are undergoing clinically-indicated coronary angiography and are receiving optimal statin therapy.

3 secondary outcomes

Nominal change in TAV and normalized TAV of an intermediate SVG lesion from baseline to 78 weeks
Time frame: 78 weeks
Angiographic failure of target SVG lesion from baseline to 78 weeks.
Time frame: 78 weeks
Incidence of target SVG failure and major adverse cardiac events.
Time frame: Randomization to 80 weeks

Results and safety

The study was stopped early (reason given: Withdrawal of medication and funding support by Sponsor). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Background: PubMed 11092659Domanski MJ, Borkowf CB, Campeau L, Knatterud GL, White C, Hoogwerf B, Rosenberg Y, Geller NL. Prognostic factors for atherosclerosis progression in saphenous vein grafts: the postcoronary artery bypass graft (Post-CABG) trial. Post-CABG Trial Investigators. J Am Coll Cardiol. 2000 Nov 15;36(6):1877-83. doi: 10.1016/s0735-1097(00)00973-6.
Background: PubMed 18841653DeFrances CJ, Lucas CA, Buie VC, Golosinskiy A. 2006 National Hospital Discharge Survey. Natl Health Stat Report. 2008 Jul 30;(5):1-20.
Background: PubMed 16287955Alexander JH, Hafley G, Harrington RA, Peterson ED, Ferguson TB Jr, Lorenz TJ, Goyal A, Gibson M, Mack MJ, Gennevois D, Califf RM, Kouchoukos NT; PREVENT IV Investigators. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA. 2005 Nov 16;294(19):2446-54. doi: 10.1001/jama.294.19.2446.
Background: PubMed 21768550Sabik JF 3rd. Understanding saphenous vein graft patency. Circulation. 2011 Jul 19;124(3):273-5. doi: 10.1161/CIRCULATIONAHA.111.039842. No abstract available.
Background: PubMed 19890125Shroyer AL, Grover FL, Hattler B, Collins JF, McDonald GO, Kozora E, Lucke JC, Baltz JH, Novitzky D; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. On-pump versus off-pump coronary-artery bypass surgery. N Engl J Med. 2009 Nov 5;361(19):1827-37. doi: 10.1056/NEJMoa0902905.
Background: PubMed 15582312Goldman S, Zadina K, Moritz T, Ovitt T, Sethi G, Copeland JG, Thottapurathu L, Krasnicka B, Ellis N, Anderson RJ, Henderson W; VA Cooperative Study Group #207/297/364. Long-term patency of saphenous vein and left internal mammary artery grafts after coronary artery bypass surgery: results from a Department of Veterans Affairs Cooperative Study. J Am Coll Cardiol. 2004 Dec 7;44(11):2149-56. doi: 10.1016/j.jacc.2004.08.064.
Background: PubMed 8772748Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol. 1996 Sep;28(3):616-26. doi: 10.1016/0735-1097(96)00206-9.
Background: PubMed 19778774Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Holper EM, Haagen D, Saeed B, Iturbe JM, Shunk K, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S, Brilakis ES. Clinical presentation and angiographic characteristics of saphenous vein graft failure after stenting: insights from the SOS (stenting of saphenous vein grafts) trial. JACC Cardiovasc Interv. 2009 Sep;2(9):855-60. doi: 10.1016/j.jcin.2009.06.014.
Background: PubMed 24643432Brilakis ES, Lee M, Mehilli J, Marmagkiolis K, Rodes-Cabau J, Sachdeva R, Kotsia A, Christopoulos G, Rangan BV, Mohammed A, Banerjee S. Saphenous vein graft interventions. Curr Treat Options Cardiovasc Med. 2014 May;16(5):301. doi: 10.1007/s11936-014-0301-x.
Background: PubMed 9185633Ellis SG, Brener SJ, DeLuca S, Tuzcu EM, Raymond RE, Whitlow PL, Topol EJ. Late myocardial ischemic events after saphenous vein graft intervention--importance of initially "nonsignificant" vein graft lesions. Am J Cardiol. 1997 Jun 1;79(11):1460-4. doi: 10.1016/s0002-9149(97)00171-9.
Background: PubMed 12595843Knatterud GL, White C, Geller NL, Campeau L, Forman SA, Domanski M, Forrester JS, Gobel FL, Herd JA, Hickey A, Hoogwerf BJ, Hunninghake DB, Terrin ML, Rosenberg Y. Angiographic changes in saphenous vein grafts are predictors of clinical outcomes. Am Heart J. 2003 Feb;145(2):262-9. doi: 10.1067/mhj.2003.113.
Background: PubMed 17697821Rodes-Cabau J, Facta A, Larose E, DeLarochelliere R, Dery JP, Nguyen CM, Roy L, Proulx G, Gleeton O, Barbeau G, Noel B, Rouleau J, Boudreault JR, Bertrand OF. Predictors of aorto-saphenous vein bypass narrowing late after coronary artery bypass grafting. Am J Cardiol. 2007 Aug 15;100(4):640-5. doi: 10.1016/j.amjcard.2007.03.080. Epub 2007 Jun 27.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emmanouil S Brilakis, MD, PhD study chair

Minneapolis Heart Institute and Foundation/ Abbott Northwestern Hospital-Allina Health

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alirocumab 150 MG/ML subcutaneous injection in people with Saphenous Vein Graft Atherosclerosis, run by Minneapolis Heart Institute Foundation at 4 sites in United States.

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 5 inclusion and 7 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 (reason given: Withdrawal of medication and funding support by Sponsor). 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?

Nominal change in intermediate SVG lesion percent atheroma volume (PAV) from baseline to 78 weeks post randomization, as assessed by intravascular ultrasonography (IVUS). (time frame: 78 weeks). 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 NCT03542110, which also lists 16 linked publications.

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 16 Sep 2021.