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Coronary Artery DiseasePhase 4NCT06139952

Ameliorating Contrast Induced Nephropathy After Coronary Angiography

A Phase 4 study testing Atorvastatin 80mg, N-acetyl cysteine and Normal Saline in people with Coronary Artery Disease and Nephropathy; Toxic, Drugs, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Given the limited understanding of the impact of statin and N-acetyl cysteine use before angiography in preventing contrast-induced nephropathy (CIN), the objective of this study is to evaluate the effectiveness of atorvastatin in preventing CIN among patients undergoing coronary angiography. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Atorvastatin 80mg, N-acetyl cysteine and Normal Saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteEgypt
Study dates
1 Dec 2023to 1 Jul 2024
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Undergoing elective Coronary angiography who will receive coronary angiography contrast media.
  • Must have at least two consecutive serum creatinine measurements (Before and after Contrast exposure)

Who cannot join

  • Pregnant or lactating women
  • Patients with Serum creatinine conc of >2.1 mg/Dl
  • Patients undergoing emergency primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.
  • Prior exposure to contrast media within 7 days
  • Contraindication for a high-dose statin, N-acetyl Cysteine prescription

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • The Cardiovascular Hospital

    Heliopolis, Cairo Governorate, 11355

Other trials in Egypt

About this study

Official title: Assessment of the Effect of Atorvastatin and N-acetyl Cysteine on Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary Angiography CIN

Given the limited understanding of the impact of statin and N-acetyl cysteine use before angiography in preventing contrast-induced nephropathy (CIN), the objective of this study is to evaluate the effectiveness of atorvastatin in preventing CIN among patients undergoing coronary angiography.

Read the detailed description

A multi armed randomized controlled clinical trial to be conducted from June 2023.According to inclusion and exclusion criteria, All patients presenting to the Cardiology department at Ain Shams University hospitals, will be assessed for eligibility. At least 120 patients subjected to elective CT coronary angiography who are at risk of developing contrast-induced renal failure will be enrolled. The participants will be assigned to Three groups (40 patients for each group):

  • Three groups
  • High-dose Atorvastatin group: 40 patients will receive 80 mg Atorvastatin before coronary angiography and will receive adequate hydration using (1ml/kg/hr)
  • N-acetyl cysteine group: 40 patients will receive 200mg 3 times daily 2 days before coronary angiography and 2 days after and will receive adequate hydration using (1ml/kg/hr)
  • Control group: 40 patients will receive adequate hydration using (1ml/kg/hr) The blood sample will be collected from all patients before the administration of contrast media and after 24 hours for assessment of the needed parameters.
Being tested
Atorvastatin 80mg, N-acetyl cysteine, Normal Saline
Keywords
Contrast Induced Nephropathy, Percutaneous Coronary Intervention
Medical subject headings
Coronary Artery Disease, Kidney Diseases

What participants receive

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

  • Atorvastatin 80mgDrug

    Atorvastatin 80mg taken Once before coronary angiography

  • N-acetyl cysteineDrug

    200mg 3 times daily 2 days before coronary angiography

  • Normal SalineOther

    adequate hydration using Normal Saline (1ml/kg/hr)

Study groups in NCT06139952
Study groupRoleWhat they receive
High-dose Atorvastatin groupExperimental40 patients will receive 80 mg Atorvastatin before coronary angiography and will receive adequate hydration using (1ml/kg/hr)
Receives: Drug: Atorvastatin 80mg
N-acetyl cysteine groupExperimental40 patients will receive 200mg 3 times daily 2 days before coronary angiography and 2 days after and will receive adequate hydration using (1ml/kg/hr)
Receives: Drug: N-acetyl cysteine
Control groupActive comparator40 patients will receive adequate hydration using (1ml/kg/hr)
Receives: Drug: Atorvastatin 80mg; Drug: N-acetyl cysteine; Other: Normal Saline

What is being measured

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

  1. Contrast induced nephropathy (CIN) incidence

    Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 24-48 hours after the procedure.

    Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 24-48 hours after the procedure.

    Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 24-48 hours after the procedure.

    Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 24-48 hours after the procedure.

    Contrast-induced nephropathy was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels

    Measured: 24-48 hours after PCI

Secondary outcomes (1)

  1. Serum Creatinine (S.Cr) level

    Measured: 48 hours after PCI

Timeline

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

  1. First posted18 Nov 2023
  2. Study start1 Dec 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Jul 2024

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective single blinded multi armed randomized controlled clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06139952
Sponsor's protocol ID
23
Status last verified
Jul 2024
First submitted
15 Nov 2023
Last updated
11 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang Y, Song M, Liu Y, Liu H, Sun L, Peng Y, Liu F, Venkatachalam MA, Dong Z. Renoprotective approaches and strategies in acute kidney injury. Pharmacol Ther. 2016 Jul;163:58-73. doi: 10.1016/j.pharmthera.2016.03.015. Epub 2016 Apr 22.

    PubMed 27108948

  • van der Molen AJ, Reimer P, Dekkers IA, Bongartz G, Bellin MF, Bertolotto M, Clement O, Heinz-Peer G, Stacul F, Webb JAW, Thomsen HS. Post-contrast acute kidney injury. Part 2: risk stratification, role of hydration and other prophylactic measures, patients taking metformin and chronic dialysis patients : Recommendations for updated ESUR Contrast Medium Safety Committee guidelines. Eur Radiol. 2018 Jul;28(7):2856-2869. doi: 10.1007/s00330-017-5247-4. Epub 2018 Feb 7.

    PubMed 29417249

  • Chong E, Poh KK, Lu Q, Zhang JJ, Tan N, Hou XM, Ong HY, Azan A, Chen SL, Chen JY, Ali RM, Fang WY, Lau TW, Tan HC. Comparison of combination therapy of high-dose oral N-acetylcysteine and intravenous sodium bicarbonate hydration with individual therapies in the reduction of Contrast-induced Nephropathy during Cardiac Catheterisation and Percutaneous Coronary Intervention (CONTRAST): A multi-centre, randomised, controlled trial. Int J Cardiol. 2015 Dec 15;201:237-42. doi: 10.1016/j.ijcard.2015.07.108. Epub 2015 Aug 5.

    PubMed 26301645

  • Ma WQ, Zhao Y, Wang Y, Han XQ, Zhu Y, Liu NF. Comparative efficacy of pharmacological interventions for contrast-induced nephropathy prevention after coronary angiography: a network meta-analysis from randomized trials. Int Urol Nephrol. 2018 Jun;50(6):1085-1095. doi: 10.1007/s11255-018-1814-0. Epub 2018 Feb 5.

    PubMed 29404930

  • Xie W, Liang X, Lin Z, Liu M, Ling Z. Latest Clinical Evidence About Effect of Acetylcysteine on Preventing Contrast-Induced Nephropathy in Patients Undergoing Angiography: A Meta-Analysis. Angiology. 2021 Feb;72(2):105-121. doi: 10.1177/0003319720950162. Epub 2020 Aug 24.

    PubMed 32830526

  • Sabry S, Ammar MK, Taeima M, Nassar N, ElFiky A, Saleh A. Preventing Contrast-Induced Acute Kidney Injury in Egyptian Patients Undergoing Coronary Angiography: A Randomized Controlled Trial. Clin Drug Investig. 2026 Apr;46(4):467-477. doi: 10.1007/s40261-026-01524-4. Epub 2026 Feb 17.

    PubMed 41701447

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin 80mg, N-acetyl cysteine and Normal Saline in people with Coronary Artery Disease and Nephropathy; Toxic, Drugs, run by Ain Shams University at 1 site in Egypt.

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 5 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: finished, as of the sponsor's last update on 11 Jul 2024. 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 Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Contrast induced nephropathy (CIN) incidence (time frame: 24-48 hours after PCI). 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 NCT06139952, which also lists 6 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 11 Jul 2024.

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