Heart FailurePhase 4VIC-MINCT06812546
Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction
A Phase 4 study testing Vericiguat in people with Heart Failure and Acute Myocardial Infarction (AMI), run by Dongying Zhang at 1 site in China.
Trial summary
Heart failure (HF) is a severe cardiovascular disease with extremely high morbidity and mortality rates worldwide, and ischemic cardiomyopathy is an important cause of heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Myocardial Infarction (AMI), Acute Heart Failure (AHF)
- What is being tested?
- Vericiguat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Dec 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Undertaking revascularization for criminal coronary artery during hospitalization
- Acute heart failure occurs within 14 days in hospital after STEMI or NSTEMI, meeting all of the following criteria: typical symptoms or signs of heart failure; Treatment with oral or intravenous diuretics is required; LVEF measured by echocardiography is ≤ 45%; Elevated levels of NT proBNP in patients with sinus rhythm ≥ 1000pg/ml and atrial fibrillation/flutter ≥ 1600pg/ml
- eGFR ≥ 15 ml/min/1.73m2
- Informed consent has to be given in written form
Who cannot join
- Plan to undergo staged revascularization or if the criminal coronary artery has not been successfully opened
- Severe and uncontrolled lung diseases, such as newly developed pulmonary embolism, primary pulmonary hypertension, acute exacerbation of COPD, etc
- Severe liver and kidney dysfunction, Child Pugh grade C or eGFR < 15ml/min/1.73m2
- Allergies to ACEI, ARB, ARNI, beta blockers, SGLT2i, MRA, Vericiguat, and other medications
- Symptomatic hypotension or systolic blood pressure less than 90mmHg after discontinuing intravenous medication
- Women in the perinatal period or those planning to conceive
Show all 11Show fewer
- Patients planning to undergo elective surgical treatment or tumor chemotherapy
- Diagnosed as Takotsubo cardiomyopathy or nonobstructive acute myocardial infarction (MINOCA)
- Previous diagnosis of cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, etc.
- Autoimmune disease or infectious diseases with typical cardiovascular damage, such as syphilis, systemic lupus erythematosus, etc.
- Diagnosed with severe heart valve disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400000
Lei Gao, M.D., 86-15123908507, 653161583@qq.com
About this study
Heart failure (HF) is a severe cardiovascular disease with extremely high morbidity and mortality rates worldwide, and ischemic cardiomyopathy is an important cause of heart failure. Vericiguat is a soluble guanylate cyclase stimulator which has been verified to improve the cardiovascular outcomes in heart failure patients. The VICTORIA trial excluded patients with acute coronary syndrome in 3 months prior to the study start, so it is still unclear about the efficacy and safety of vericiguat in heart failure after acute myocardial infarction. So we conducted this multi-center, prospective, cohort study to estimate the efficacy and safety of vericiguat in HF patients after acute myocardial infarction.
Read the detailed description
Heart failure (HF) is a severe cardiovascular disease with extremely high morbidity and mortality rates worldwide, and ischemic cardiomyopathy is an important cause of heart failure. According to different studies, acute heart failure occurs in-hospital in about 14-36% of patients after acute myocardial infarction (AMI)1 and the presence of HF on admission or the occurrence of HF during hospitalization in patients with AMI are strong risk factors for poor prognosis. The incidence of HF in AMI varies according to population differences. For example, in patients with STEMI, the incidence of acute heart failure is relatively high because of the greater extent of the infarction and the longer duration of coronary occlusion, whereas patients with NSTEMI, although at lower risk of developing heart failure in the acute phase, have an increased risk of developing chronic heart failure in the long term. Advanced age, previous history of heart failure, chronic kidney disease, multibranch vasculopathy, and delayed opening of the infarct-related artery are major risk factors. In addition, comorbidities such as diabetes and hypertension increase the risk of developing heart failure.
The goals of treatment for HF after AMI are to improve cardiac function, reduce symptoms, and prevent further myocardial injury. Basic therapy consists of prompt opening of the infarct-related artery (e.g., percutaneous coronary intervention) and the administration of optimized pharmacological treatments such as antiplatelets, beta-blockers, ACEI/ARBs and aldosterone antagonists. In the acute phase, diuretics and positive inotropic agents may be used to relieve severe symptoms. Besides, other HF medication such as SGLT2i are effective in patients with heart failure whether or not it is caused by ischemia.
Vericiguat is a soluble guanylate cyclase stimulator which has been verified to improve the cardiovascular outcomes in heart failure patients. The VICTORIA trial excluded patients with acute coronary syndrome in 3 months prior to the study start, so it is still unclear about the efficacy and safety of vericiguat in heart failure after acute myocardial infarction. The VIC-MI trial is a multi-center, prospective, open-label cohort study to estimate the efficacy and safety of vericiguat in HF patients after acute myocardial infarction.
- Being tested
- Vericiguat
- Keywords
- Vericiguat, Guideline-Directed Medical Therapy, Heart Failure, Acute myocardial infarction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
Also called BAY1021189
Patients enrolled in the experimental group will receive 26 weeks of oral vericiguat on top of the standard treatment, with vericiguat at a dose of 2.5 mg once a day, doubled every fortnight to a maximum dose of 10 mg once a day at the end of week 6 of the visit, which will be maintained for the duration of the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat Treatment Group | Experimental | Patients enrolled in the experimental group will receive 26 weeks of oral vericiguat on top of the standard treatment, with vericiguat at a dose of 2.5 mg once a day, doubled every fortnight to a maximum dose of 10 mg once a day at the end of week 6 of the visit, which will be maintained for the duration of the treatment. Receives: Drug: Vericiguat |
| Standard Treatment Group | No intervention | Patients enrolled in the controlled group will receive 26 weeks of standard heart failure and coronary heart disease treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum NT-proBNP Level
The primary endpoint of the study is NT-proBNP at the baseline \& at the completion of the 24 week intervention
Measured: Up to 24 weeks
Secondary outcomes (6)
6-minute walk distance
6-minute walk distance at the baseline \& at the completion of the 24 week intervention
Measured: Up to 24 weeks
NYHA functional class
NYHA functional class at the baseline \& at the completion of the 24 week intervention
Measured: Up to 24 weeks
Worsening heart failure event
Time to first worsening heart failure event in 24 weeks after randomization
Measured: Up to 24 weeks
Left ventricular ejection fraction
LVEF measured by echocardiography at the baseline \& at the completion of the 24 weeks intervention
Measured: Up to 24 weeks
Left ventricular end-diastolic diameter
LVEDD measured by echocardiography at the baseline \& at the completion of the 24 week intervention
Measured: Up to 24 weeks
Left ventricular global longitudinal strain
GLS measured by echocardiography at the baseline \& at the completion of the 24 week intervention
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter, prospective, randomized controlled trial in which patients will be randomized into either the experimental or control group by uniform stratification from the main centre.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongying Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Chongqing Medical University
- Responsible party
- Sponsor-investigator, Dongying Zhang, Chongqing Emergency Medical Center
- Investigators
- Dongying Zhang, Professor, Study chair, Chongqing Central Hospital of Chongqing University, Chongqing Emergency Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812546
- Sponsor's protocol ID
- VIC-MI
- Other IDs
- 82300372; 82270406, CSTB2024NSCQ-LZX0144, 2022MSXM028
- Acronym
- VIC-MI
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share IPD is not decided yet
Publications
Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28.
PubMed 32222134Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27.
PubMed 34449189McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
PubMed 31535829Juilliere Y, Cambou JP, Bataille V, Mulak G, Galinier M, Gibelin P, Benamer H, Bouvaist H, Meneveau N, Tabone X, Simon T, Danchin N; FAST-MI Investigators. Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry. Rev Esp Cardiol (Engl Ed). 2012 Apr;65(4):326-33. doi: 10.1016/j.recesp.2011.10.027. Epub 2012 Feb 20.
PubMed 22357361Bahit MC, Lopes RD, Clare RM, Newby LK, Pieper KS, Van de Werf F, Armstrong PW, Mahaffey KW, Harrington RA, Diaz R, Ohman EM, White HD, James S, Granger CB. Heart failure complicating non-ST-segment elevation acute coronary syndrome: timing, predictors, and clinical outcomes. JACC Heart Fail. 2013 Jun;1(3):223-9. doi: 10.1016/j.jchf.2013.02.007. Epub 2013 Jun 3.
PubMed 24621874Steg PG, Dabbous OH, Feldman LJ, Cohen-Solal A, Aumont MC, Lopez-Sendon J, Budaj A, Goldberg RJ, Klein W, Anderson FA Jr; Global Registry of Acute Coronary Events Investigators. Determinants and prognostic impact of heart failure complicating acute coronary syndromes: observations from the Global Registry of Acute Coronary Events (GRACE). Circulation. 2004 Feb 3;109(4):494-9. doi: 10.1161/01.CIR.0000109691.16944.DA. Epub 2004 Jan 26.
PubMed 14744970Bahit MC, Kochar A, Granger CB. Post-Myocardial Infarction Heart Failure. JACC Heart Fail. 2018 Mar;6(3):179-186. doi: 10.1016/j.jchf.2017.09.015.
PubMed 29496021
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Early Initiation of Vericiguat in Heart Failure After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06812546
- Acronym / sponsor ID
- VIC-MI / VIC-MI
- Keywords
- Vericiguat, Guideline-Directed Medical Therapy, Heart Failure, Acute myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dongying ZhangUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Chongqing Medical University
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Feb 2025 (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.
Heart failure (HF) is a severe cardiovascular disease with extremely high morbidity and mortality rates worldwide, and ischemic cardiomyopathy is an important cause of heart failure. Vericiguat is a soluble guanylate cyclase stimulator which has been verified to improve the cardiovascular outcomes in heart failure patients. The VICTORIA trial excluded patients with acute coronary syndrome in 3 months prior to the study start, so it is still unclear about the efficacy and safety of vericiguat in heart failure after acute myocardial infarction. So we conducted this multi-center, prospective, cohort study to estimate the efficacy and safety of vericiguat in HF patients after acute myocardial infarction.
Detailed description
Heart failure (HF) is a severe cardiovascular disease with extremely high morbidity and mortality rates worldwide, and ischemic cardiomyopathy is an important cause of heart failure. According to different studies, acute heart failure occurs in-hospital in about 14-36% of patients after acute myocardial infarction (AMI)1 and the presence of HF on admission or the occurrence of HF during hospitalization in patients with AMI are strong risk factors for poor prognosis. The incidence of HF in AMI varies according to population differences. For example, in patients with STEMI, the incidence of acute heart failure is relatively high because of the greater extent of the infarction and the longer duration of coronary occlusion, whereas patients with NSTEMI, although at lower risk of developing heart failure in the acute phase, have an increased risk of developing chronic heart failure in the long term. Advanced age, previous history of heart failure, chronic kidney disease, multibranch vasculopathy, and delayed opening of the infarct-related artery are major risk factors. In addition, comorbidities such as diabetes and hypertension increase the risk of developing heart failure.
The goals of treatment for HF after AMI are to improve cardiac function, reduce symptoms, and prevent further myocardial injury. Basic therapy consists of prompt opening of the infarct-related artery (e.g., percutaneous coronary intervention) and the administration of optimized pharmacological treatments such as antiplatelets, beta-blockers, ACEI/ARBs and aldosterone antagonists. In the acute phase, diuretics and positive inotropic agents may be used to relieve severe symptoms. Besides, other HF medication such as SGLT2i are effective in patients with heart failure whether or not it is caused by ischemia.
Vericiguat is a soluble guanylate cyclase stimulator which has been verified to improve the cardiovascular outcomes in heart failure patients. The VICTORIA trial excluded patients with acute coronary syndrome in 3 months prior to the study start, so it is still unclear about the efficacy and safety of vericiguat in heart failure after acute myocardial infarction. The VIC-MI trial is a multi-center, prospective, open-label cohort study to estimate the efficacy and safety of vericiguat in HF patients after acute myocardial infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a multicenter, prospective, randomized controlled trial in which patients will be randomized into either the experimental or control group by uniform stratification from the main centre.
| Arm | Type | Receives |
|---|---|---|
| Vericiguat Treatment Group | Experimental | Drug: VericiguatPatients enrolled in the experimental group will receive 26 weeks of oral vericiguat on top of the standard treatment, with vericiguat at a dose of 2.5 mg once a day, doubled every fortnight to a maximum dose of 10 mg once a day at the end of week 6 of the visit, which will be maintained for the duration of the treatment. |
| Standard Treatment Group | No intervention | –Patients enrolled in the controlled group will receive 26 weeks of standard heart failure and coronary heart disease treatment |
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 old
- Undertaking revascularization for criminal coronary artery during hospitalization
- Acute heart failure occurs within 14 days in hospital after STEMI or NSTEMI, meeting all of the following criteria: typical symptoms or signs of heart failure; Treatment with oral or intravenous diuretics is required; LVEF measured by echocardiography is ≤ 45%; Elevated levels of NT proBNP in patients with sinus rhythm ≥ 1000pg/ml and atrial fibrillation/flutter ≥ 1600pg/ml
- eGFR ≥ 15 ml/min/1.73m2
- Informed consent has to be given in written form
Key exclusion criteria (11 listed)
- Plan to undergo staged revascularization or if the criminal coronary artery has not been successfully opened
- Severe and uncontrolled lung diseases, such as newly developed pulmonary embolism, primary pulmonary hypertension, acute exacerbation of COPD, etc
- Severe liver and kidney dysfunction, Child Pugh grade C or eGFR < 15ml/min/1.73m2
- Allergies to ACEI, ARB, ARNI, beta blockers, SGLT2i, MRA, Vericiguat, and other medications
- Symptomatic hypotension or systolic blood pressure less than 90mmHg after discontinuing intravenous medication
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 |
|---|---|---|
| VericiguatAlso: BAY1021189Patients enrolled in the experimental group will receive 26 weeks of oral vericiguat on top of the standard treatment, with vericiguat at a dose of 2.5 mg once a day, doubled every fortnight to a maximum dose of 10 mg once a day at the end of week 6 of the visit, which will be maintained for the duration of the treatment. | Drug | Vericiguat Treatment Group |
Primary outcome
Serum NT-proBNP Level
Time frame: Up to 24 weeks
The primary endpoint of the study is NT-proBNP at the baseline \& at the completion of the 24 week intervention
6 secondary outcomes
6-minute walk distance
Time frame: Up to 24 weeks
NYHA functional class
Time frame: Up to 24 weeks
Worsening heart failure event
Time frame: Up to 24 weeks
Left ventricular ejection fraction
Time frame: Up to 24 weeks
Left ventricular end-diastolic diameter
Time frame: Up to 24 weeks
Left ventricular global longitudinal strain
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Results publication: PubMed 32222134Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28.
- Results publication: PubMed 34449189Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27.
- Results publication: PubMed 31535829McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
- Results publication: PubMed 22357361Juilliere Y, Cambou JP, Bataille V, Mulak G, Galinier M, Gibelin P, Benamer H, Bouvaist H, Meneveau N, Tabone X, Simon T, Danchin N; FAST-MI Investigators. Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry. Rev Esp Cardiol (Engl Ed). 2012 Apr;65(4):326-33. doi: 10.1016/j.recesp.2011.10.027. Epub 2012 Feb 20.
- Results publication: PubMed 24621874Bahit MC, Lopes RD, Clare RM, Newby LK, Pieper KS, Van de Werf F, Armstrong PW, Mahaffey KW, Harrington RA, Diaz R, Ohman EM, White HD, James S, Granger CB. Heart failure complicating non-ST-segment elevation acute coronary syndrome: timing, predictors, and clinical outcomes. JACC Heart Fail. 2013 Jun;1(3):223-9. doi: 10.1016/j.jchf.2013.02.007. Epub 2013 Jun 3.
- Results publication: PubMed 14744970Steg PG, Dabbous OH, Feldman LJ, Cohen-Solal A, Aumont MC, Lopez-Sendon J, Budaj A, Goldberg RJ, Klein W, Anderson FA Jr; Global Registry of Acute Coronary Events Investigators. Determinants and prognostic impact of heart failure complicating acute coronary syndromes: observations from the Global Registry of Acute Coronary Events (GRACE). Circulation. 2004 Feb 3;109(4):494-9. doi: 10.1161/01.CIR.0000109691.16944.DA. Epub 2004 Jan 26.
- Results publication: PubMed 29496021Bahit MC, Kochar A, Granger CB. Post-Myocardial Infarction Heart Failure. JACC Heart Fail. 2018 Mar;6(3):179-186. doi: 10.1016/j.jchf.2017.09.015.
- Individual participant dataSharing planned: Undecided. The plan to share IPD is not decided yet
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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.
Dongying Zhang, Professor study chair
Chongqing Central Hospital of Chongqing University, Chongqing Emergency Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vericiguat in people with Heart Failure and Acute Myocardial Infarction (AMI), run by Dongying Zhang at 1 site in China.
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 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: opening soon, as of the sponsor's last update on 6 Feb 2025. 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 China. 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 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?
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?
Contact Dongying Zhang, Professor (86-13608398395, zhangdongying@cqu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum NT-proBNP Level (time frame: Up to 24 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 NCT06812546, which also lists 7 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 6 Feb 2025.