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Acute Coronary SyndromeBioVascNCT03621501

Direct Complete Versus Staged Complete Revascularization in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease

A study testing Percutaneous coronary intervention in people with Acute Coronary Syndrome, run by Erasmus Medical Center at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

To test whether immediate complete revascularization is non-inferior to staged (but within six weeks after index procedure) complete revascularization in Patients presenting with ACS, including Non-ST-elevation ACS (NSTEACS) and ST-elevation myocardial infarction (STEMI), with multivessel disease accepted for PCI Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Percutaneous coronary intervention
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,525 participants
Where
1 siteNetherlands
Study dates
22 Jun 2018to 31 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inclusion criteria STEMI-ACS ST-segment elevation myocardial infarction (STEMI) Both criteria must be present for eligibility
  • Chest pain for more than 20 minutes with an electrocardiographic ST-segment elevation of 1 mm or greater in two or more contiguous leads, or with a new left bundle-branch block
  • Admission either within 12 hours of symptom onset or between 12 and 24 hours after onset with evidence of continuing ischemia.
  • Inclusion criteria for NSTE-ACS Non-ST-segment elevation myocardial infarction (NSTEMI) At least two of the following must be present for eligibility
  • History consistent with new, or worsening ischemia, occurring at rest or with minimal activity
  • Coronary angiography with indication to PCI
Show all 18Show fewer
  • Troponin T or I or creatine kinase MB above the upper limit of normal
  • Electrocardiographic changes compatible with ischemia but not diagnostic for ST-segment elevation myocardial infarction (i.e. ST depression of 1 mm or greater in two contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts) 0 Unstable Angina (UA)
  • At least two of the following must be present in the absence of cardiomyocyte necrosis (i.e. Troponin T or I and creatine kinase MB must be within normal limits):
  • History consistent with new, or worsening ischemia, occurring at rest or with minimal activity
  • Coronary angiography with indication to PCI
  • Electrocardiographic changes compatible with ischemia but not diagnostic for ST-segment elevation myocardial infarction (i.e. ST depression of 1 mm or greater in two contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts)
  • General inclusion criteria:
  • Age ≥ 18 years ≤ 85 years
  • The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki
  • Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Biotronik Orsiro (Sirolimus-Eluting stent) system.
  • The patient is willing and able to cooperate with study procedures and the required follow up visits
  • The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization

Who cannot join

  • Age <18 years and > 85 years
  • Single coronary vessel disease or multivessel disease without clear culprit
  • Patients in cardiogenic shock
  • Patients who cannot give informed consent or have a life expectancy of less than 1year
  • Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors.
  • Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint . The patient may only be enrolled once in the BioVAsc study
Show all 11Show fewer
  • PCI in the previous 30 days.
  • Presence of a chronic total occlusion
  • Previous CABG
  • Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding.
  • Planned surgery within 6 months after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

Official title: Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndrome and Multivessel Disease

To test whether immediate complete revascularization is non-inferior to staged (but within six weeks after index procedure) complete revascularization in Patients presenting with ACS, including Non-ST-elevation ACS (NSTEACS) and ST-elevation myocardial infarction (STEMI), with multivessel disease accepted for PCI

Read the detailed description

Invasive coronary angiography followed by percutaneous coronary intervention is the treatment of choice in patient presenting with STEMI-ACS1 and NSTE-ACS2. Up to 60 percent of these patients have multivessel disease on angiography3-5. Patients with multivessel disease have a worse prognosis compared with patients having culprit vessel disease only5. It has been debated whether a complete or culprit artery only revascularization strategy is better.

Retrospective data in STEMI patients suggested a lower mortality in patients that were treated with culprit artery only compared with multivessel PCI during index procedure6. Since then, four randomized controlled trials have addressed this question in STEMI population; The Randomized Trial of Preventive Angioplasty in Acute Myocardial Infarction (PRAMI) trial (n = 465, 23 months follow-up)7, the Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease (CvLPRIT) (n = 296, 12months follow-up)8, the Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI) trial (n = 627, 27months follow-up)9, and the Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction (Compare-Acute) trial (n = 885, 12 months follow-up)10. PCI of the non-infarct related artery was performed at the index procedure (PRAMI and Compare-Acute), staged before discharge (DANAMI-3-PRIMULTI) or at any time during hospitalization (CvLPRIT). Indication for PCI was significant stenosis as assessed by angiography (PRAMI and CvLPRIT) or FFR (DANAMI-3-PRIMULTI and COMPARE-ACUTE). There was a significant reduction in primary outcome in all four trials in favor of complete revascularization. However, there was no significant reduction in total mortality or myocardial infarction. Based on the results for these four trials, the 2017 ESC STEMI-ACS guidelines gave a class II, level of evidence (LOE) A, indication for routine complete revascularization in STEMI patients with multivessel disease, including those presenting with cardiogenic shock1. However, an important shortcoming of the abovementioned studies is the absence of a staged complete revascularization arm. As there is no data that compare immediate and staged complete revascularization, the guidelines don't advise on when to perform non-infarct related artery revascularization.

Data regarding optimal treatment in NSTEMI-ACS are more scarce. In an observational study by Shishesbor and coworkers, they showed that nonculprit multivessel stenting reduced future revascularization rate but this was not associated with lower rate of death or myocardial infarction11. Recently, a substudy from the Bleeding complications in a Multicenter registry of patients discharged with diagnosis of acute coronary syndrome (BleeMACS) registry (N=4520 patients, 1459 NSTEMI) was published12. They showed that in NSTEMI patients, complete revascularization was associated with a significant lower rate of death (4.5% vs. 8.5%; p=0.002), re-AMI (3.7% vs. 6.6%; p=0.016) and MACE (8.1% vs. 13.9%; p=0.001) at one year follow up. The 2015 ESC NSTEMI-ACS guidelines not specifically advise a culprit only or multivessel PCI strategy. Moreover, they advise to base revascularization strategy on patients clinical status and co-morbidities, as well as disease severity, Class II, LEO B. Interestingly, in contrast with the STEMI population, in NSTEMI population there is a small RCT investigating staged versus direct complete revascularization , the Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients: The SMILE Trial (N=584 patients)13. There was a significant reduction in primary endpoint 1S-PCI: n = 36 [13.63%] vs. MS-PCI: n = 61 [23.19%]; hazard ratio [HR]: 0.549 [95% confidence interval (CI): 0.363 to 0.828]; p = 0.004) at one year follow up. This was mainly driven by a reduction in target vessel revascularization. There was no significant difference in cardiac death or myocardial infarction between the both groups. This finding deserves further investigation, because the TVR rate (15.4% at 1 year) in the multistage group was unprecedentedly high in the era of current-generation drug-eluting stents.

There is no publication specifically addressing the patients with unstable angina regarding the subject of complete or incomplete revascularization or timing of revascularization.

Considering such data, complete revascularization in ACS patients seems advisable, but timing of revascularization is unknown.

Given this background no investigation so far provided a comprehensive evaluation of the complete revascularization strategies for patients with any type of acute coronary syndrome and multivessel disease. Therefore, the investigators aim to investigate in a randomized controlled trial the commonly used complete revascularization strategies for patients presenting with ACS: 1) Immediate complete revascularization 2) Culprit only plus staged complete revascularization within six weeks after index procedure, in terms of the primary endpoint, the composite of death from any cause, nonfatal type 1 myocardial infarction, revascularization, and cerebrovascular events at 1-year post intervention.

Patients will be treated with one commercially available second-generation drug-eluting stent stent to ensure homogeneity of treatment among patients, abolishing the occurrence of bias due to different stent usage. The stents used will be the Biotronik Orsiro DES (Sirolimus-Eluting stent). The Orsiro DES is a second generation DES with a bioabsorbable polymer coating releasing sirolimus and was CE marketed in 2011. The bioabsorbable nature of the polymer could be associated with a reduction of the inflammatory response, reducing neo-intima growth compared to a durable polymer14, 15. The active drug sirolimus is a lipophilic molecule that inhibits mammalian target of rapamycine (mTOR) on smooth muscle cells, also preventing neo-intima hyperplasia16. The Orsiro stent has ultrathin cobalt chromium struts of 60-80micron (depending on stent size) enhancing deliverability and crossability without loss of radial strength or fatigue resistance. The Orsiro stent has been extensively studied in different study populations with more than 32.500 patients studied globally.

Being tested
Percutaneous coronary intervention
Keywords
Percutaneous coronary intervention, Multivessel disease
Medical subject headings
Acute Coronary Syndrome

What participants receive

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

  • Percutaneous coronary interventionDevice

    Also called PCI

    At the index procedure, the culprit lesion (cause of complaints/acute coronary syndrome) will be treated according to standard of care with a Biotronik Orsiro DES (Sirolimus-Eluting stent). If there are additional significant lesions besides the culprit lesion, patients will be randomized to direct complete revascularization or staged complete revascularization. In the direct complete revascularization group all lesions will be treated during the index procedure. In the staged complete revascularization group, only the culprit lesion will be treated during the index procedure. The remaining significant lesions will be treated later but within six weeks after the index procedure. In both arms the additional lesions will also be treated with Biotronik Orsiro DES (Sirolimus-Eluting stent).

Study groups in NCT03621501
Study groupRoleWhat they receive
Staged complete revascularizationPlacebo comparator• Culprit only + staged (within six weeks after index procedure) complete revascularization in all vessels ≥ 2.5mm with ≥ 70% stenosis by visual estimation or positive coronary physiology test per operator's discretion (Control arm)
Receives: Device: Percutaneous coronary intervention
Immediate complete revascularizationActive comparator• Immediate complete revascularization in all vessels ≥ 2.5mm with ≥ 70% stenosis by visual estimation or positive coronary physiology test per operator's discretion (Experimental arm)
Receives: Device: Percutaneous coronary intervention

What is being measured

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

  1. MACCE

    a composite clinical outcome of all-cause mortality, myocardial infarction, any unplanned ischemia driven revascularization, and cerebrovascular events

    Measured: 1 year

Secondary outcomes (22)

  1. MACCE

    Composite clinical outcome of all-cause mortality, myocardial infarction, any unplanned ischemia driven revascularization, and cerebrovascular events

    Measured: 30 days

  2. MACCE

    Composite clinical outcome of all-cause mortality, myocardial infarction, any unplanned ischemia driven revascularization, and cerebrovascular events

    Measured: 2 years

  3. MACCE

    Composite clinical outcome of all-cause mortality, myocardial infarction, any unplanned ischemia driven revascularization, and cerebrovascular events

    Measured: 5 years

  4. All cause mortality

    All cause mortality

    Measured: 30 days

  5. All cause mortality

    All cause mortality

    Measured: 1 year

  6. All cause mortality

    All cause mortality

    Measured: 2 years

  7. All cause mortality

    All cause mortality

    Measured: 5 years

  8. Myocardial infarction

    Myocardial Infarction

    Measured: 30 days

  9. Myocardial infarction

    Myocardial Infarction

    Measured: 1 year

  10. Myocardial infarction

    Myocardial Infarction

    Measured: 2 years

  11. Myocardial infarction

    Myocardial Infarction

    Measured: 5 years

  12. Coronary revascularization

    Any unplanned ischemia driven coronary revascularization procedure

    Measured: 30 days

  13. Coronary revascularization

    Any unplanned ischemia driven coronary revascularization procedure

    Measured: 1 year

  14. Coronary revascularization

    Any unplanned ischemia driven coronary revascularization procedure

    Measured: 2 years

  15. Coronary revascularization

    Any unplanned ischemia driven coronary revascularization procedure

    Measured: 5 years

  16. Major bleeding

    Major bleeding (not related to coronary-artery bypass grafting, BARC 3-5)

    Measured: 30 days

  17. Major bleeding

    Major bleeding (not related to coronary-artery bypass grafting, BARC 3-5)

    Measured: 1 year

  18. Need for renal replacement therapy

    Need for renal replacement therapy

    Measured: 30 days

  19. Quality of Life Seattle Angina Questionnaire

    Seattle Angina Questionnaire. Scale 1-5. Higher values represent better outcome

    Measured: 30 days

  20. Quality of life Seattle Angina Questionnaire

    Seattle Angina Questionnaire. Scale 1-5. Higher values represent better outcome

    Measured: 1 year

  21. Quality of Life EQ5D

    EQ5D EQ5D EQ5D. Scale 1-5. Higher values represent worse outcome

    Measured: 30 days

  22. Quality of life EQ5D

    EQ5D. Scale 1-5. Higher values represent worse outcome

    Measured: 1 year

Timeline

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

  1. First posted8 Aug 2018
  2. Study start22 Jun 2018
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2026 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a prospective, multicenter, randomized, two-arm, international, open-label, non-inferiority study. Due to the design characteristics of the study, the study investigators and operators cannot be blinded.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,525 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03621501
Sponsor's protocol ID
BioVasc protocol definitive
Acronym
BioVasc
Status last verified
Nov 2022
First submitted
8 Feb 2018
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

    PubMed 28886621

  • Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.

    PubMed 26320110

  • D'Ascenzo F, Presutti DG, Picardi E, Moretti C, Omede P, Sciuto F, Novara M, Yan AT, Goodman S, Mahajan N, Kosuge M, Palazzuoli A, Jong GP, Isma'eel H, Budoff MJ, Rubinshtein R, Gewirtz H, Reed MJ, Theroux P, Biondi-Zoccai G, Modena MG, Sheiban I, Gaita F. Prevalence and non-invasive predictors of left main or three-vessel coronary disease: evidence from a collaborative international meta-analysis including 22 740 patients. Heart. 2012 Jun;98(12):914-9. doi: 10.1136/heartjnl-2011-301596.

    PubMed 22626899

  • Fox KA, Poole-Wilson PA, Henderson RA, Clayton TC, Chamberlain DA, Shaw TR, Wheatley DJ, Pocock SJ; Randomized Intervention Trial of unstable Angina Investigators. Interventional versus conservative treatment for patients with unstable angina or non-ST-elevation myocardial infarction: the British Heart Foundation RITA 3 randomised trial. Randomized Intervention Trial of unstable Angina. Lancet. 2002 Sep 7;360(9335):743-51. doi: 10.1016/s0140-6736(02)09894-x.

    PubMed 12241831

  • Park DW, Clare RM, Schulte PJ, Pieper KS, Shaw LK, Califf RM, Ohman EM, Van de Werf F, Hirji S, Harrington RA, Armstrong PW, Granger CB, Jeong MH, Patel MR. Extent, location, and clinical significance of non-infarct-related coronary artery disease among patients with ST-elevation myocardial infarction. JAMA. 2014 Nov 19;312(19):2019-27. doi: 10.1001/jama.2014.15095.

    PubMed 25399277

  • Hannan EL, Samadashvili Z, Walford G, Holmes DR Jr, Jacobs AK, Stamato NJ, Venditti FJ, Sharma S, King SB 3rd. Culprit vessel percutaneous coronary intervention versus multivessel and staged percutaneous coronary intervention for ST-segment elevation myocardial infarction patients with multivessel disease. JACC Cardiovasc Interv. 2010 Jan;3(1):22-31. doi: 10.1016/j.jcin.2009.10.017.

    PubMed 20129564

  • Wald DS, Morris JK, Wald NJ, Chase AJ, Edwards RJ, Hughes LO, Berry C, Oldroyd KG; PRAMI Investigators. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med. 2013 Sep 19;369(12):1115-23. doi: 10.1056/NEJMoa1305520. Epub 2013 Sep 1.

    PubMed 23991625

  • Gershlick AH, Khan JN, Kelly DJ, Greenwood JP, Sasikaran T, Curzen N, Blackman DJ, Dalby M, Fairbrother KL, Banya W, Wang D, Flather M, Hetherington SL, Kelion AD, Talwar S, Gunning M, Hall R, Swanton H, McCann GP. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015 Mar 17;65(10):963-72. doi: 10.1016/j.jacc.2014.12.038.

    PubMed 25766941

  • Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.

    PubMed 26347918

  • Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.

    PubMed 28317428

  • Shishehbor MH, Lauer MS, Singh IM, Chew DP, Karha J, Brener SJ, Moliterno DJ, Ellis SG, Topol EJ, Bhatt DL. In unstable angina or non-ST-segment acute coronary syndrome, should patients with multivessel coronary artery disease undergo multivessel or culprit-only stenting? J Am Coll Cardiol. 2007 Feb 27;49(8):849-54. doi: 10.1016/j.jacc.2006.10.054. Epub 2007 Feb 8.

    PubMed 17320742

  • Quadri G, D'Ascenzo F, Moretti C, D'Amico M, Raposeiras-Roubin S, Abu-Assi E, Henriques JPS, Saucedo J, Gonzalez-Juanatey JR, Wilton SB, Kikkert WJ, Nunez-Gil I, Ariza-Sole A, Song X, Alexopoulos D, Liebetrau C, Kawaji T, Huczek Z, Nie SP, Fujii T, Correia L, Kawashiri MA, Garcia-Acuna JM, Southern D, Alfonso E, Terol B, Garay A, Zhang D, Chen Y, Xanthopoulou I, Osman N, Mollmann H, Shiomi H, Omede P, Montefusco A, Giordana F, Scarano S, Kowara M, Filipiak K, Wang X, Yan Y, Fan JY, Ikari Y, Nakahashi T, Sakata K, Yamagishi M, Kalpak O, Kedev S, Varbella F, Gaita F. Complete or incomplete coronary revascularisation in patients with myocardial infarction and multivessel disease: a propensity score analysis from the "real-life" BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry. EuroIntervention. 2017 Jul 20;13(4):407-414. doi: 10.4244/EIJ-D-16-00350.

    PubMed 28169217

  • Sardella G, Lucisano L, Garbo R, Pennacchi M, Cavallo E, Stio RE, Calcagno S, Ugo F, Boccuzzi G, Fedele F, Mancone M. Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients: The SMILE Trial. J Am Coll Cardiol. 2016 Jan 26;67(3):264-72. doi: 10.1016/j.jacc.2015.10.082.

    PubMed 26796390

  • Koppara T, Joner M, Bayer G, Steigerwald K, Diener T, Wittchow E. Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation. Thromb Haemost. 2012 Jun;107(6):1161-71. doi: 10.1160/TH12-01-0043. Epub 2012 Apr 26.

    PubMed 22535188

  • Koppara T, Wittchow E, Byrne RA, Bayer G, Diener T, Joner M. Permanent and biodegradable polymer coatings in the absence of antiproliferative drugs in a porcine model of coronary artery stenting. EuroIntervention. 2016 Jan 22;11(9):1020-6. doi: 10.4244/EIJY14M10_08.

    PubMed 25317851

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous coronary intervention in people with Acute Coronary Syndrome, run by Erasmus Medical Center at 1 site in Netherlands.

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 18 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

MACCE (time frame: 1 year). 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 NCT03621501, which also lists 22 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 8 Nov 2022.

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